Identity
- Trade Name
- Polymer Guide kit FDA UDI
- Generic Name
- Dental implant/prosthesis surgical procedure kit FDA UDI
- Device Name
- Dental Implant surgery Guide tool FDA UDI
- Model / Reference
- PGSCK FDA UDI
- Description
- Dental Implant surgery Guide tool FDA UDI
Identifiers
- Catalog Number
- PGSCK FDA UDI
- Primary DI / UDI-DI
- 08809552962406 FDA UDI
- FDA Product Code
- EJL FDA UDI
- GMDN Term
- Dental implant/prosthesis surgical procedure kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3240 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 7 Centimeter FDA UDI
Category: Dental implant/prosthesis surgical procedure kit
Polymer Guide kit by Genoss — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental implant/prosthesis surgical procedure kit.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Genoss
Sources (1)
- FDA UDI c5d1b015-b6c7-46dd-bcb7-5ade1bcc973f 36 fields · synced Jun 1, 2026