FDA UDI
In Commercial Distribution
🇺🇸 United States
WASHER HEAD FOR FIXER GUIDE Ø1.7X8
DI: 07899995201751
·
Model: AFG 17
·
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
- WASHER HEAD FOR FIXER GUIDE Ø1.7X8
- Primary DI
- 07899995201751
- Version / Model
- AFG 17
- 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
- 2023-07-21
- Public Version
- 1
- Public Version Date
- 2023-07-31
- Public Version Status
- New
- Public Device Record Key
- ed8edd95-a4b7-46db-a809-f12bdcdbc166
Device Description
WASHER HEAD FOR FIXER GUIDE Ø1.7X8
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| NDP | Accessories, Implant, Dental, Endosseous | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64371 | Dental implantation drilling template guide-sleeve | A small tubular device intended to be inserted within the guide holes of a dental implantation drilling template (a device used to guide drilling in the jawbone during dental implant placement/fixation) to guide the implant into position. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07899995201751 | GS1 |