Identity
- Trade Name
- ERISMA® LP_NAVIGATED INSTRUMENTS FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- ERISMA-LP NAV CANNULATED TAP D8.5MM FDA UDI
- Model / Reference
- 48701185 FDA UDI
- Description
- ERISMA-LP NAV CANNULATED TAP D8.5MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700780638246 FDA UDI
- 510(k) Number
- K202956 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 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_navigated Instruments by Clariance, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K202956 also covers:
- ERISMA® LP_NAVIGATED INSTRUMENTS — Clariance, Inc.
- ERISMA® LP_NAVIGATED INSTRUMENTS — Clariance, Inc.
- ERISMA® LP_NAVIGATED INSTRUMENTS — Clariance, Inc.
- ERISMA® LP_NAVIGATED INSTRUMENTS — Clariance, Inc.
- ERISMA® LP_NAVIGATED INSTRUMENTS — Clariance, Inc.
- ERISMA® LP_NAVIGATED INSTRUMENTS — Clariance, Inc.
- ERISMA® LP_NAVIGATED INSTRUMENTS — Clariance, Inc.
- ERISMA® LP_NAVIGATED INSTRUMENTS — Clariance, Inc.
- ERISMA® LP_NAVIGATED INSTRUMENTS — Clariance, Inc.
- ERISMA® LP_NAVIGATED INSTRUMENTS — Clariance, Inc.
- ERISMA® LP_NAVIGATED INSTRUMENTS — Clariance, Inc.
- ERISMA® LP_NAVIGATED INSTRUMENTS — 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 |
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Manufacturer
- Manufacturer
- Clariance, Inc.
Sources (1)
- FDA UDI 8ea690f1-31c9-444a-9588-ebb008b463f4 35 fields · synced May 30, 2026