FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SureClip
DI: 46932503530307
·
Model: ROCC-F-26-235-C
·
Micro-Tech (Nanjing) Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- SureClip
- Primary DI
- 46932503530307
- Version / Model
- ROCC-F-26-235-C
- Catalog Number
- ROCC-F-26-235-C
- Company Name
- Micro-Tech (Nanjing) Co., Ltd.
- Labeler DUNS
- 530269083
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-03-21
- Public Version
- 4
- Public Version Date
- 2024-08-20
- Public Version Status
- Update
- Public Device Record Key
- 474fd279-742d-45d6-b90d-9ad66737837a
- Distribution End Date
- 2024-07-31
Device Description
Open width16±2mm the max OD of insertion part 2.6mm working length 2350mm coated, 2 pcs in the box
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PKL | Hemostatic Metal Clip For The Gi Tract | Gastroenterology, Urology | 876.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61207 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 66932503530301 | GS1 | case | 25 | Not in Commercial Distribution | 2024-07-31 |
| Package | 56932503530304 | GS1 | box | 2 | Not in Commercial Distribution | 2024-07-31 |
| Primary | 46932503530307 | GS1 |