FDA UDI
In Commercial Distribution
🇺🇸 United States
SURGICAL INSTRUMENT
DI: 07899995299482
·
Model: GFU 2027E
·
Sin Sistema de Implante Nacional S/A
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SURGICAL INSTRUMENT
- Primary DI
- 07899995299482
- Version / Model
- GFU 2027E
- Catalog Number
- GFU 2027E
- Company Name
- Sin Sistema de Implante Nacional S/A
- Labeler DUNS
- 904569092
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-24
- Public Version
- 1
- Public Version Date
- 2021-04-01
- Public Version Status
- New
- Public Device Record Key
- 53d58c29-1b67-44c7-92f4-b9c40b9c5071
Device Description
GUIDE DRILL UNIT Ø2,00/Ø2,70MM NARROW
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
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | 880.6850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45714 | Fixture/appliance dental drill bit, reusable | A shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07899995299482 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201688 | 000 |