FDA UDI
In Commercial Distribution
🇺🇸 United States
KOMET Diamond Strip, Polishing Strip
DI: E226018084A41
·
Model: DS37EF.000..A4
·
Gebr. Brasseler GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- KOMET Diamond Strip, Polishing Strip
- Primary DI
- E226018084A41
- Version / Model
- DS37EF.000..A4
- Catalog Number
- DS37EF.000.
- Company Name
- Gebr. Brasseler GmbH & Co. KG
- Labeler DUNS
- 317409001
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2023-02-01
- Public Version
- 1
- Public Version Date
- 2023-02-09
- Public Version Status
- New
- Public Device Record Key
- c06b6193-c2d0-4e15-80c3-b04fe855cb89
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EHM | STRIP, POLISHING AGENT | Dental | 872.6010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63358 | Dental abrasive strip, reusable | A manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying (e.g., polishing, finishing, contouring, reducing) the surface of a tooth or restoration during a dental procedure. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | E226018084A48 | HIBCC | ||||
| Primary | E226018084A41 | HIBCC |