NA
- Primary DI
- 26926839812349
- Brand
- NA
- Company
- Anrei Medical(HZ) Co.,Ltd.
- Model
- M00591010
- Catalog number
- M00591010
- Device description
- Clip
- Published
- 2025-10-27
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| PKL | Hemostatic Metal Clip For The Gi Tract |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| PKL | Hemostatic Metal Clip For The Gi Tract | Gastroenterology, Urology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K201771 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 26926839812349 | Package | GS1 | 10 | In Commercial Distribution |
| 26926839812356 | Package | GS1 | 20 | In Commercial Distribution |
| 16926839812335 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 26926839812349 | 26926839812349 |
| 26926839812356 | 26926839812356 |
| 16926839812335 | 16926839812335 |
GMDN Terms#
| Term | Definition |
|---|---|
| Gastrointestinal endoscopic clip, long-term, non-bioabsorbable | A non-bioabsorbable clip intended to be implanted long-term (>30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, treating mucosal/submucosal defects, and/or as part of bariatric procedures. It is a metallic device with a clasping mechanism; a disposable applicator may be included. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 529128653
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 16948318903921 | Rescue | M00515100 | M00515100 | 2021-05-14 |
| 16948318903822 | Rescue | M00527450 | M00527450 | 2019-03-01 |
| 16948318903907 | Rescue | M00527650 | M00527650 | 2019-02-28 |
| 16948318903938 | Rescue | M00527750 | M00527750 | 2019-02-28 |
| 16948318903983 | Rescue | M00538350 | M00538350 | 2019-03-01 |
| 16948318968807 | Rescue | M00527550 | M00527550 | 2019-02-28 |
| 16926839812335 | NA | M00591010 | M00591010 | 2025-10-27 |
| 16926839812366 | NA | M00591200 | M00591200 | 2025-10-27 |
| 16926839812397 | NA | M00591210 | M00591210 | 2025-10-27 |
| 16926839812427 | NA | M00591220 | M00591220 | 2025-10-27 |
| 16926839812458 | NA | M00591230 | M00591230 | 2025-10-27 |
| 16926839812489 | NA | M00591240 | M00591240 | 2025-10-27 |
| 16926839812519 | NA | M00591250 | M00591250 | 2025-10-27 |
| 16926839812304 | NA | M00591000 | M00591000 | 2025-10-27 |
| 26926839812370 | NA | M00591200 | M00591200 | 2025-10-27 |
| 26926839812400 | NA | M00591210 | M00591210 | 2025-10-27 |
| 26926839812431 | NA | M00591220 | M00591220 | 2025-10-27 |
| 26926839812462 | NA | M00591230 | M00591230 | 2025-10-27 |
| 26926839812493 | NA | M00591240 | M00591240 | 2025-10-27 |
| 26926839812523 | NA | M00591250 | M00591250 | 2025-10-27 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 10197344203437 | MEDLINE | MEDLINE INDUSTRIES, INC. | PKL | 2026-04-23 |
| 10197344203444 | MEDLINE | MEDLINE INDUSTRIES, INC. | PKL | 2026-04-23 |
| 00860014822704 | EndoFix Tissue Fixation Device | Endofix Medical Technologies, Inc. | PKL | 2026-02-02 |
| 00860014822711 | Secure Suture Locking Device | Endofix Medical Technologies, Inc. | PKL | 2026-02-02 |
| 46932503530819 | Lockado(TM) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | 2025-12-06 |
| 46932503530833 | Lockado(TM) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | 2025-12-06 |
| 46932503530840 | Lockado(TM) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | 2025-12-06 |
| 46932503530864 | Lockado(TM) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | 2025-12-06 |
| 46932503530871 | Lockado(TM) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | 2025-12-06 |
| 46932503530895 | Lockado(TM) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | 2025-12-06 |
| 46932503530918 | Lockado(TM) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | 2025-12-06 |
| 46932503530932 | Lockado(TM) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | 2025-12-06 |
| 46932503530956 | Lockado(TM) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | 2025-12-06 |
| 46932503530970 | Lockado(TM) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | 2025-12-06 |
| 46932503530994 | Lockado(TM) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | 2025-12-06 |
| 46932503535012 | Lockado(TM) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | 2025-12-06 |
| 46932503535029 | Lockado(TM) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | 2025-12-06 |
| 46932503535036 | Lockado(TM) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | 2025-12-06 |
| 46932503535043 | Lockado(TM) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | 2025-12-06 |
| 46932503535050 | Lockado(TM) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | 2025-12-06 |
| 46932503530666 | RiteClip(TM) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | 2025-12-02 |
| 46932503530727 | RiteClip(TM) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | 2025-12-02 |
| 46932503530390 | SureClip(®MINI) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | 2025-11-30 |
| 46932503530413 | SureClip(®MINI) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | 2025-11-30 |
| 46932503530420 | SureClip(®) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | 2025-11-30 |
| 46932503530444 | SureClip(®) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | 2025-11-30 |
| 46932503530451 | SureClip(®PLUS) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | 2025-11-30 |
| 46932503530468 | SureClip(®PLUS) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | 2025-11-30 |
| 46932503530512 | SureClip(®MAX) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | 2025-11-30 |
| 46932503530529 | SureClip(®MAX) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | 2025-11-30 |