FDA UDI
In Commercial Distribution
🇺🇸 United States
OSSIO® Compression Screw Instruments For 3.5 mm Screws
DI: 07290017630915
·
Model: THN00132
·
OSSIO LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OSSIO® Compression Screw Instruments For 3.5 mm Screws
- Primary DI
- 07290017630915
- Version / Model
- THN00132
- Catalog Number
- THN00132
- Company Name
- OSSIO LTD
- Labeler DUNS
- 600505107
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-14
- Public Version
- 1
- Public Version Date
- 2022-09-22
- Public Version Status
- New
- Public Device Record Key
- 1004c0e5-9755-4b98-b363-72660736e8aa
Device Description
OSSIO® Compression Screw Instruments For 3.5 mm Screws. Package contains: 1 Instrument Pack.
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
- Yes
- 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 |
|---|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44052 | Orthopaedic surgical procedure kit, non-medicated, single-use | A collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290017630915 | GS1 |
Customer Contacts
- Phone
- 1-833-781-7373
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Instruments For 3.5 mm Diameter Screws |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry