FDA UDI
In Commercial Distribution
🇺🇸 United States
InnoClip
DI: 14717480902306
·
Model: TRC-H0000
·
TAIWAN SURGICAL CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- InnoClip
- Primary DI
- 14717480902306
- Version / Model
- TRC-H0000
- 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
- 280fd546-269d-4b40-81b7-ad944b6bccbd
Device Description
Reusable Clip Applier Handle
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 |
|---|---|---|---|---|
| 58050 | Ligation clip cartridge holder | A device designed to hold sterile ligation clip cartridges to facilitate quick reloading of the cartridges into a surgical clip applier during a surgical procedure. It is typically made of metal and plastic materials in the form of a flat and stable base with profiled slots in its upper surface into which many ligation clip cartridges are held ready for loading. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 14717480902306 | GS1 |