FDA UDI
In Commercial Distribution
🇺🇸 United States
Inion GTR instrument
DI: M224INS905210
·
Model: 1
·
Inion Oy
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Inion GTR instrument
- Primary DI
- M224INS905210
- Version / Model
- 1
- Catalog Number
- INS-9052
- Company Name
- Inion Oy
- Labeler DUNS
- 367994657
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 4
- Public Version Date
- 2019-08-14
- Public Version Status
- Update
- Public Device Record Key
- a48fd26b-7eaa-4531-b3c6-531eabc7ee21
Device Description
Re-usable tack applicator
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| NPK | Barrier, synthetic, intraoral | Dental | 872.3930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47746 | Bone tack inserter, basic | A hand-held manual surgical instrument designed to drive (insert) a tack into bone, typically to fixate an orthopaedic plate or sheet. It is typically formed with a shaft made of high-grade stainless steel and a handle at the proximal end made of metal or synthetic material. The distal end is designed to hold (grip) the head of the tack head during insertion, typically through a hole in the plate or sheet and into a pre-drilled hole in the bone. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M224INS905210 | HIBCC | ||||
| Secondary | 06438408005596 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K033074 | 000 |