Identity
- Trade Name
- CEMSTOP FDA UDI
- Generic Name
- Polymer orthopaedic cement restrictor, bioabsorbable FDA UDI
- Model / Reference
- Diameter 12 FDA UDI
Identifiers
- Catalog Number
- T770012 FDA UDI
- Primary DI / UDI-DI
- 03760177040496 FDA UDI
- FDA Product Code
- LZN FDA UDI
- GMDN Term
- Polymer orthopaedic cement restrictor, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 12 Millimeter FDA UDI
Category: Polymer orthopaedic cement restrictor, bioabsorbable
Cemstop by Teknimed — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polymer orthopaedic cement restrictor, bioabsorbable.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Teknimed
Sources (1)
- FDA UDI 5483772a-73ba-4752-b362-68f127f01dfc 35 fields · synced May 30, 2026