FDA UDI
In Commercial Distribution
🇺🇸 United States
HU-FRIEDY
DI: 10889950006907
·
Model: CR20
·
HU-FRIEDY MFG. CO., LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HU-FRIEDY
- Primary DI
- 10889950006907
- Version / Model
- CR20
- Catalog Number
- CR20
- Company Name
- HU-FRIEDY MFG. CO., LLC
- Labeler DUNS
- 005085972
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-12
- Public Version
- 1
- Public Version Date
- 2020-11-20
- Public Version Status
- New
- Public Device Record Key
- bb0525ff-56d9-483b-9a06-4a914caa037b
Device Description
#20 Esthetic Carving Knife GKR20/21
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
- 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 |
|---|---|---|---|---|
| EKH | CARVER, DENTAL AMALGAM, OPERATIVE | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41544 | Periodontal knife | A hand-held dental instrument used to excise the gums and other oral soft tissue during a periodontal intervention (e.g., a gingivectomy involving the excising of the soft tissue wall of a pocket). It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade of various shapes and sizes along the working end. It can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10889950006907 | GS1 |
Customer Contacts
- Phone
- +1(800)483-7433
- [email protected]