FDA UDI
In Commercial Distribution
🇺🇸 United States
BioHorizons
DI: 00847236000646
·
Model: CGS-BMC-10
·
BIOHORIZONS IMPLANT SYSTEMS, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BioHorizons
- Primary DI
- 00847236000646
- Version / Model
- CGS-BMC-10
- Company Name
- BIOHORIZONS IMPLANT SYSTEMS, INC
- Labeler DUNS
- 967279910
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-31
- Public Version
- 4
- Public Version Date
- 2021-08-13
- Public Version Status
- Update
- Public Device Record Key
- 71b77383-c4b7-4113-a684-6d5f1a8c75d7
Device Description
5.8mm CGS Master Cylinder (pack of 10)
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
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NDP | Accessories, Implant, Dental, Endosseous | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64371 | Dental implantation drilling template guide-sleeve | A small tubular device intended to be inserted within the guide holes of a dental implantation drilling template (a device used to guide drilling in the jawbone during dental implant placement/fixation) to guide the implant into position. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00847236000646 | GS1 |