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Synthacer
FDA UDIClass II (US FDA UDI)
by medArtis Medizinprodukte und Forschung Aktiengesellschaft
Identity
- Trade Name
- Synthacer FDA UDI
- Generic Name
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
- Device Name
- Synthacer® 300 cylinder, HA, size 7, diameter 9.45 mm, length 25 mm, without lid FDA UDI
- Model / Reference
- T6107TMO-1 FDA UDI
- Description
- Synthacer® 300 cylinder, HA, size 7, diameter 9.45 mm, length 25 mm, without lid FDA UDI
Identifiers
- Catalog Number
- 6.107TMO FDA UDI
- Primary DI / UDI-DI
- 04250971400873 FDA UDI
- 510(k) Number
- K041177 FDA UDI
- FDA Product Code
- MQV FDA UDI
- GMDN Term
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3045 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 25 Millimeter FDA UDIOuter Diameter — 9.45 Millimeter FDA UDIPore Size — 300 Micrometer FDA UDI
Category: Bone matrix implant, synthetic, non-antimicrobial
Synthacer by medArtis Medizinprodukte und Forschung Aktiengesellschaft — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K041177 also covers:
- Synthacer — medArtis Medizinprodukte und Forschung Aktiengesellschaft
- Synthacer — medArtis Medizinprodukte und Forschung Aktiengesellschaft
- Synthacer — medArtis Medizinprodukte und Forschung Aktiengesellschaft
- Synthacer — medArtis Medizinprodukte und Forschung Aktiengesellschaft
- Synthacer — medArtis Medizinprodukte und Forschung Aktiengesellschaft
- Synthacer — medArtis Medizinprodukte und Forschung Aktiengesellschaft
- Synthacer — medArtis Medizinprodukte und Forschung Aktiengesellschaft
- Synthacer — medArtis Medizinprodukte und Forschung Aktiengesellschaft
- Synthacer — medArtis Medizinprodukte und Forschung Aktiengesellschaft
- Synthacer — medArtis Medizinprodukte und Forschung Aktiengesellschaft
- Synthacer — medArtis Medizinprodukte und Forschung Aktiengesellschaft
- Synthacer — medArtis Medizinprodukte und Forschung Aktiengesellschaft
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
Sources (1)
- FDA UDI 62d344be-aaa6-4b64-8d7f-c6f95806ee0f 36 fields · synced Jun 8, 2026