FDA UDI
In Commercial Distribution
🇺🇸 United States
Tac, dental
DI: E0HM36MTAB09
·
Model: MTAB0
·
Hager & Meisinger Gesellschaft mit beschränkter Haftung
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Tac, dental
- Primary DI
- E0HM36MTAB09
- Version / Model
- MTAB0
- Catalog Number
- MTAB0
- Company Name
- Hager & Meisinger Gesellschaft mit beschränkter Haftung
- Labeler DUNS
- 318034329
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2015-07-13
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 598fa8a9-5fe1-4f01-ad75-8b9169820964
Device Description
Tacs are used for the fixation of membranes (resorbable membranes nonresorbable membranes) to the bone structure. Tacs are intended for single use only. The Tacs consist of titanium alloy Grade 5 and are delivered non sterile.
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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| DZL | Screw, Fixation, Intraosseous | Dental | 872.4880 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46640 | Craniofacial bone tack, non-bioabsorbable | A small, sterile, cylindrical shaft typically with a flat, rounded head at one end and tapered to a point at the other, that is driven into craniofacial bone (includes maxilla and/or mandible) to provide stabilization for fracture repair and reconstructive procedures; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., titanium alloy). The device may be used when rigid fixation with bone plates and screws is not required. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | E0HM36MTAB09 | HIBCC | ||||
| Unit of Use | E0HM36MTAB0 | HIBCC |
Customer Contacts
- Phone
- +1 (303) 268-5400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130682 | 000 |