FDA UDI
In Commercial Distribution
🇺🇸 United States
NITINEX
DI: 00841731139962
·
Model: SK-3030
·
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
- 00841731139962
- Version / Model
- SK-3030
- Catalog Number
- SK-3030
- 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
- e37086ff-a0c6-4e4e-8951-1fa986f3a1cf
Device Description
NITINEX Implant Surgical Kit, 30mm x 30mm, 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 |
|---|---|---|---|---|
| 65867 | Orthopaedic bone staple drill bit | A thin shaft of metal with a sharp distal end intended to drill a small diameter hole into a small bone for insertion of an orthopaedic bone staple, typically for fixation following osteotomy. It may include markings to help gauge the size of the staple to be used and is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841731139962 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231493 | 000 |