FDA UDI
In Commercial Distribution
🇺🇸 United States
Supremo Instrumentos
DI: 07908854000159
·
Model: S9011-TB
·
ANDRE GREGATE BRAGA INSTRUMENTOS LTDA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Supremo Instrumentos
- Primary DI
- 07908854000159
- Version / Model
- S9011-TB
- Catalog Number
- S9011-TB
- Company Name
- ANDRE GREGATE BRAGA INSTRUMENTOS LTDA
- Labeler DUNS
- 921478697
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-20
- Public Version
- 1
- Public Version Date
- 2024-05-28
- Public Version Status
- New
- Public Device Record Key
- 5ca5eb56-eeae-40d4-a805-5aef3d38d2e8
Device Description
Tunnel Blade - TB2
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DZN | Instruments, Dental Hand | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12235 | Scalpel handle, reusable | A device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07908854000159 | GS1 |