Identity
- Trade Name
- i-FACTOR™ Peptide Enhanced Bone Graft FDA UDI
- Generic Name
- Bone matrix implant, animal-derived, bioabsorbable FDA UDI
- Device Name
- i-FACTOR™ Putty, 5.0 cc Syringe FDA UDI
- Model / Reference
- 700-050 FDA UDI
- Description
- i-FACTOR™ Putty, 5.0 cc Syringe FDA UDI
Identifiers
- Catalog Number
- 700-050 FDA UDI
- Primary DI / UDI-DI
- M8517000501 FDA UDI
- PMA Number
- P140019 FDA UDI
- FDA Product Code
- NOX FDA UDI
- GMDN Term
- Bone matrix implant, animal-derived, bioabsorbable FDA UDI
Classification
- Device Class
- Class III 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
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bone matrix implant, animal-derived, bioabsorbable
i-FACTOR™ Peptide Enhanced Bone Graft by Cerapedics, LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone matrix implant, animal-derived, bioabsorbable.
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- Opus™ BA Strip — COLLAGEN MATRIX, INC. · Class II
Cleared under the same submission
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 III | Pending data |
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Manufacturer
- Manufacturer
- Cerapedics, LLC
Sources (1)
- FDA UDI 0faa4c35-837f-407a-bed4-207b594db186 37 fields · synced May 30, 2026