FDA UDI
In Commercial Distribution
🇺🇸 United States
Inion GTR™
DI: M224MBR20009
·
Model: 1
·
Inion Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Inion GTR™
- Primary DI
- M224MBR20009
- Version / Model
- 1
- Catalog Number
- MBR-2000
- Company Name
- Inion Oy
- Labeler DUNS
- 367994657
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-07
- Public Version
- 5
- Public Version Date
- 2023-12-21
- Public Version Status
- Update
- Public Device Record Key
- 73a6e6f2-bfdf-46c4-a343-469763af4b85
- Distribution End Date
- 2026-10-01
Device Description
Membrane 30x40 mm
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
- No
- 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 |
|---|---|---|---|---|
| NPK | Barrier, synthetic, intraoral | Dental | 872.3930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58503 | Pliable-polymer dental regeneration membrane, bioabsorbable, tacked | A sterile bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, by acting as a barrier to prevent the down-growth of soft tissue (connective tissue and epithelial cells) into the underlying bone during the healing period. It is a synthetic polymer material that is held in place with bioabsorbable tacks fixed into the jawbone; it is applied between soft tissue and bone during periodontal flap surgery and other guided bone regeneration (GBR) and guided tissue regeneration (GTR) surgical procedures. The tacks and a plasticizer used to temporarily soften the membrane may be included. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M224MBR20009 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K033074 | 000 |