NA
- Primary DI
- 66959664900446
- Brand
- NA
- Company
- Hangzhou AGS MedTech Co., Ltd.
- Model
- AG-5012-2316
- Published
- 2019-04-23
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- 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 |
|---|---|
| K172727 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 16959664900441 | Package | GS1 | 10 | In Commercial Distribution |
| 26959664900448 | Package | GS1 | 10 | In Commercial Distribution |
| 36959664900445 | Package | GS1 | 2 | In Commercial Distribution |
| 46959664900442 | Package | GS1 | 25 | In Commercial Distribution |
| 56959664900449 | Package | GS1 | 5 | In Commercial Distribution |
| 66959664900446 | Package | GS1 | 10 | In Commercial Distribution |
| 06959664900444 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 16959664900441 | 16959664900441 | |
| 26959664900448 | 26959664900448 | |
| 36959664900445 | 36959664900445 | |
| 46959664900442 | 46959664900442 | |
| 56959664900449 | 56959664900449 | |
| 66959664900446 | 66959664900446 | |
| 06959664900444 | 06959664900444 | 6959664900444 |
GMDN Terms#
| Term | Definition |
|---|---|
| Gastrointestinal endoscopic clip, short-term | A sterile clip intended to be placed short-term (<=30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and/or for treating mucosal/submucosal defects. It is a metallic device with a clasping mechanism; a disposable applicator may be included. This is a single-use device. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Humidity | 0 Percent (%) Relative Humidity | 80 Percent (%) Relative Humidity | |
| Storage Environment Temperature | -10 Degrees Celsius | 40 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 542984702
- 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
- true
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 06959664905203 | NA | AG-50114-2312 | 2026-05-15 | |
| 06959664905210 | NA | AG-50114-2316 | 2026-05-15 | |
| 06959664905227 | NA | AG-50114-2318 | 2026-05-15 | |
| 06959664905234 | NA | AG-50114-2320 | 2026-05-15 | |
| 06959664905241 | NA | AG-50114-2323 | 2026-05-15 | |
| 06959664905258 | NA | AG-50114-2327 | 2026-05-15 | |
| 06959664905265 | NA | AG-50115-2307 | 2026-05-15 | |
| 06959664905272 | NA | AG-50115-2312 | 2026-05-15 | |
| 06959664905289 | NA | AG-50115-2316 | 2026-05-15 | |
| 06959664905296 | NA | AG-50115-2318 | 2026-05-15 | |
| 06959664905302 | NA | AG-50115-2320 | 2026-05-15 | |
| 06959664905319 | NA | AG-50115-2323 | 2026-05-15 | |
| 06959664905326 | NA | AG-50115-2327 | 2026-05-15 | |
| 06959664905333 | NA | AG-50115-1807 | 2026-05-15 | |
| 06959664905340 | NA | AG-50115-1812 | 2026-05-15 | |
| 06959664905357 | NA | AG-50115-1816 | 2026-05-15 | |
| 06959664905364 | NA | AG-50115-1818 | 2026-05-15 | |
| 06959664905371 | NA | AG-50115-1820 | 2026-05-15 | |
| 06959664905388 | NA | AG-50115-1823 | 2026-05-15 | |
| 06959664905395 | NA | AG-50115-1827 | 2026-05-15 |
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 |