Identity
- Trade Name
- DHHS FDA UDI
- Generic Name
- Spiral blade FDA UDI
- Device Name
- DHHS HELIX BLADE 135MM-STERILE FDA UDI
- Model / Reference
- 282.246S FDA UDI
- Description
- DHHS HELIX BLADE 135MM-STERILE FDA UDI
Identifiers
- Catalog Number
- 282246S FDA UDI
- Primary DI / UDI-DI
- 10886982178404 FDA UDI
- FDA Product Code
- KTT FDA UDIJDO FDA UDI
- GMDN Term
- Spiral blade FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
Moist Heat or Steam Sterilization FDA UDI
Category: Spiral blade
Dhhs by Synthes — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- DHHS — Synthes · Class II
- DHHS — Synthes · Class II
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- TFN-ADVANCE — Synthes · Class II
- TFN-ADVANCE — Synthes · Class II
Cleared under the same submission
K042895 also covers:
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
- Synthes
Sources (1)
- FDA UDI c4b57347-18dc-4632-910f-a8031659b671 36 fields · synced May 30, 2026