FDA UDI
In Commercial Distribution
🇺🇸 United States
NITINEX
DI: 00841731139566
·
Model: SS-9100
·
VILEX LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NITINEX
- Primary DI
- 00841731139566
- Version / Model
- SS-9100
- Catalog Number
- SS-9100
- Company Name
- VILEX LLC
- Labeler DUNS
- 117502293
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-05
- Public Version
- 1
- Public Version Date
- 2024-12-13
- Public Version Status
- New
- Public Device Record Key
- a86816e5-0b2f-40ea-9dd8-c6bd582aee60
Device Description
NITINEX Staple Implant Sizer Assembly, Sterile
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| KDD | Kit, Surgical Instrument, Disposable | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67154 | Orthopaedic bone staple sizer | A small manual orthopaedic measuring device intended to intraoperatively determine the appropriate size of an orthopaedic staple to be implanted. It is typically in the form of a small round or rectangular plastic piece with markings or projections for direct visualisation of the dimension required. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841731139566 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231493 | 000 |