FDA UDI
In Commercial Distribution
🇺🇸 United States
Buffalo Dental Mfg
DI: 00850043381198
·
Model: 27550
·
Buffalo Dental Manufacturing Co., Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Buffalo Dental Mfg
- Primary DI
- 00850043381198
- Version / Model
- 27550
- Catalog Number
- 27550
- Company Name
- Buffalo Dental Manufacturing Co., Inc.
- Labeler DUNS
- 001372853
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-05
- Public Version
- 1
- Public Version Date
- 2022-08-15
- Public Version Status
- New
- Public Device Record Key
- 3fe9d52d-20b8-43e7-b175-61a39024c970
Device Description
Hollenbeck Carver 1/2
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| EIK | Carver, Wax, Dental | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35794 | Dental wax carver | A hand-held manual dental instrument used to carve wax patterns with a blunt blade of varying size and shape, which can be heated for softening the wax while fashioning the pattern. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850043381198 | GS1 |