FDA UDI
In Commercial Distribution
🇺🇸 United States
IS TIP
DI: 08800019110460
·
Model: STS5E3
·
B& L Biotech, inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IS TIP
- Primary DI
- 08800019110460
- Version / Model
- STS5E3
- Company Name
- B& L Biotech, inc.
- Labeler DUNS
- 687338285
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-14
- Public Version
- 1
- Public Version Date
- 2022-10-24
- Public Version Status
- New
- Public Device Record Key
- b4f5431a-944f-4af6-a3e0-823e11dfa8c6
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
- 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 |
|---|---|---|---|---|
| JET | Pick, Massaging | Dental | 872.6650 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60791 | Dental implant/teeth debridement brush, biodegradable | A rotary/oscillating dental instrument intended to be used by a dental hygienist and/or dentist for the non-surgical-invasive debridement of a patient's dental implants and/or teeth affected by peri-implant disease (peri-implant mucositis, peri-implantitis) or periodontitis. It is a brush-like device with biodegradable (e.g., chitosan) bristles at the distal end of a high-grade steel shaft. It is intended to be connected to a dental handpiece which provides the rotation or oscillation for the mechanical removal of biofilm from the surface of the implants and teeth. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800019110460 | GS1 |