Identity
- Trade Name
- ENDOVIS B.A. FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Model / Reference
- Nails extractor FDA UDI
Identifiers
- Catalog Number
- 43161 FDA UDI
- Primary DI / UDI-DI
- 08032909620326 FDA UDI
- 510(k) Number
- K113387 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 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 inorganic implant inserter/extractor, reusable
Endovis B.a. by Citieffe — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic inorganic implant inserter/extractor, reusable.
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- Vu ePOD™ — SeaSpine Orthopedics Corporation · Class II
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- PEEK Corpectomy — Nuvasive, Inc. · Class II
- TIMBERLINE LATERAL FUSION SYSTEM — BIOMET SPINE LLC · Class II
Cleared under the same submission
K113387 also covers:
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
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
- Citieffe
Sources (1)
- FDA UDI 4a904000-3b4f-49e2-9cdf-39cb4f36c15f 36 fields · synced Jun 1, 2026