FRG
- 产品代码
- FRG
- 器械名称
- Wrap, Sterilization
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 880.6850
- FDA 专业组
- General Hospital
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 323 件
该代码近三年的 510(k)（25 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K261897 | 2026-07-02 | O&M Halyard, Inc. | HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE- | FDA |
| K252823 | 2026-05-28 | Dukal, LLC | Dukal Crepe Paper Sterilization Wrap | |
| K253454 | 2026-05-18 | O&M Halyard, Inc. | HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUIC | |
| K251347 | 2026-01-28 | Sterivic Medical Co., Ltd. | Sterilization Pouch/Roll | |
| K251177 | 2025-12-12 | Guangdong Maidi Medical Co., Ltd. | Self-Seal Sterilization Pouch and Roll | |
| K250306 | 2025-10-31 | Propper Manufacturing Co., Inc. | Chex-All Sterilization Pouches and Tubes | |
| K243179 | 2025-06-26 | Yichang Xinxin Paper Products Co., Ltd | Sterilization Pouch and Roll | |
| K250321 | 2025-06-06 | George Courey, Inc. | GCI Sterilization Wrappers | |
| K243721 | 2025-04-25 | Wellmed Dental Medical Supply Co., Ltd | Self Sealing Sterilization Pouches | — |
| K250011 | 2025-04-04 | Turbett Surgical | Turbett Surgical Instrument Pod (TS1500); Turbett Su | |
| K241565 | 2025-02-24 | Anqing Clean Dental Instrument Technol | Sterilization Package/Reel | |
| K243431 | 2025-02-21 | Medicom Asia-Pacific Holdings Ltd. Tai | Medicom Sterilization Pouch and Reel | |
| K242898 | 2025-02-21 | Shanghai Jianzhong Medical Packaging C | Sterilization Pouches and Reels | |
| K240438 | 2024-11-04 | Comercializadora Brever | CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hosp | |
| K242839 | 2024-10-16 | Shenzhen Safesecure Medical Infection | Safe Secure Sterilization Pouches and Rolls | |
| K242208 | 2024-10-07 | Primed Medical Products, Inc. | PRIMED Sterilization Wrap (P100, P200, P300, P400, P | |
| K241123 | 2024-09-18 | Km Corp. | Perpak Sterilization Tyvek Pouch | |
| K234132 | 2024-09-17 | Medline Industries, LP | Medline Reusable Sterilization Wrappers | |
| K234050 | 2024-09-16 | O&M Halyard, Inc. | HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUIC | |
| K240330 | 2024-08-07 | O&M Halyard, Inc. | HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALY | |
| K240862 | 2024-06-21 | Medicom Group, Inc. | Medicom Sterilization Wrap | |
| K232625 | 2024-06-07 | Wipak OY | Steriking® Pouch for Robotic Instruments | |
| K233777 | 2024-05-24 | Primed Medical Products, Inc. | PRIMED Sterilization Wrap (P100, P200, P300, P400, P | |
| K233262 | 2024-03-22 | Dukal, LLC | Dukal SMS Sterilization Wrap | |
| K230137 | 2023-12-07 | Ahlstrom-Munksjo Nonwovens, LLC | Reliance® Fusion Sterilization Wraps |
FDA 官方分类页： FRG
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。