FDA UDI
In Commercial Distribution
🇺🇸 United States
Versipass Suture Passer Needle
DI: 00860794002679
·
Model: 4727
·
Lincotek Medical LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Versipass Suture Passer Needle
- Primary DI
- 00860794002679
- Version / Model
- 4727
- Catalog Number
- 4727
- Company Name
- Lincotek Medical LLC
- Labeler DUNS
- 117021487
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-17
- Public Version
- 1
- Public Version Date
- 2024-10-25
- Public Version Status
- New
- Public Device Record Key
- 031725ef-56c9-4cfb-8431-977265534c92
Device Description
Suture passer needle for the Versipass Suture Passer
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| GAB | Needle, Suturing, Disposable | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61143 | Suturing needle, single-use | A cylindrical-shaped, solid, metal instrument intended to be used to insert and pull suture material through tissue (e.g., skin, fascia, serous, vascular, or other tissue/organ) during surgical stitching of tissues. It is available in various lengths, curvatures, diameters, cross-sectional shapes, and distal end forms. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860794002679 | GS1 | ||||
| Package | 10860794002669 | GS1 | 5 | In Commercial Distribution |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry place