Identity
- Trade Name
- Erisma®-LP FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Snap fit tightening wrench FDA UDI
- Model / Reference
- 01720001 FDA UDI
- Description
- Snap fit tightening wrench FDA UDI
Identifiers
- Catalog Number
- 01720001 FDA UDI
- Primary DI / UDI-DI
- 03700780601530 FDA UDI
- 510(k) Number
- K120469 FDA UDI
- FDA Product Code
- MNH FDA UDIMNI FDA UDINKB FDA UDI
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic surgical procedure kit, non-medicated, reusable
Erisma®-LP by Clariance, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic surgical procedure kit, non-medicated, reusable.
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Cleared under the same submission
K120469 also covers:
- Erisma®-LP — Clariance, Inc.
- Erisma®-LP — Clariance, Inc.
- Erisma®-LP — Clariance, Inc.
- Erisma®-LP — Clariance, Inc.
- Erisma®-LP — Clariance, Inc.
- Erisma®-LP — Clariance, Inc.
- Erisma®-LP — Clariance, Inc.
- Erisma®-LP — Clariance, Inc.
- Erisma®-LP — Clariance, Inc.
- Erisma®-LP — Clariance, Inc.
- Erisma®-LP — Clariance, Inc.
- Erisma®-LP — Clariance, Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Clariance, Inc.
Sources (1)
- FDA UDI 1a19ab61-df84-445b-994f-c352465295d4 36 fields · synced Jun 6, 2026