FDA UDI
In Commercial Distribution
🇺🇸 United States
GBR System
DI: 08800041000012
·
Model: SDB-140-050
·
Surgident Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
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Basic Information
- Brand Name
- GBR System
- Primary DI
- 08800041000012
- Version / Model
- SDB-140-050
- Company Name
- Surgident Co.,Ltd.
- Labeler DUNS
- 689846448
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2018-08-31
- Public Version
- 4
- Public Version Date
- 2024-06-12
- Public Version Status
- Update
- Public Device Record Key
- 43eb21f8-af94-46e1-bae8-6a779cb1fc88
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
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 46645 | Dental regeneration membrane fixation tack, non-bioabsorbable | A non-bioabsorbable tack intended to be driven into bone to fix or stabilize bioabsorbable barrier membranes used for the regeneration of tissue and/or bone in the oral cavity, or used for other clinical situations that require membrane utilization. The device is typically made of metal (e.g., titanium alloy). This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800041000012 | GS1 | ||||
| Unit of Use | 08800041000272 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170697 | 000 |