FDA UDI
In Commercial Distribution
🇺🇸 United States
InnoClip
DI: 04717480902347
·
Model: RC5T1-B6
·
TAIWAN SURGICAL CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- InnoClip
- Primary DI
- 04717480902347
- Version / Model
- RC5T1-B6
- Company Name
- TAIWAN SURGICAL CORPORATION
- Labeler DUNS
- 657134172
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-11
- Public Version
- 2
- Public Version Date
- 2023-11-20
- Public Version Status
- Update
- Public Device Record Key
- b02bf364-dca9-4502-89d1-07e141f5af94
Device Description
Titanium Clip Cartridge, 5mm, Titanium, ML, 16 Clips
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| GDO | Applier, Surgical, Clip | General, Plastic Surgery | 878.4800 | 1 |
| FZP | Clip, Implantable | General, Plastic Surgery | 878.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35649 | Ligation clip, metallic | A metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; a dedicated, disposable clip applier may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04717480902347 | GS1 |