Identity
- Trade Name
- APTUS FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- Screw Tray APTUS Forearm 2.8 FDA UDI
- Model / Reference
- A-6607.010 FDA UDI
- Description
- Screw Tray APTUS Forearm 2.8 FDA UDI
Identifiers
- Catalog Number
- A-6607.010 FDA UDI
- Primary DI / UDI-DI
- 07630037830030 FDA UDI
- 510(k) Number
- K193554 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Device sterilization/disinfection container, reusable
Aptus by Medartis Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Device sterilization/disinfection container, reusable.
- SM - LIPO PANTY CHEVILLES COUPE TAILLE NOIR AVEC TROUS RECOUVERTS SUR MESURE — MEDICAL Z · Class I
- INSTRUMENTS TRAYS WITHOUT LID, 200x100x25MM — DAUD JEE MFG. CO · Class I
- Breastform Cover Right Size 03 (478/ 482) — Trulife · Class I
- NCB® Periprosthetic Plate System — Zimmer, Inc. · Class I
- NTOC cassette — NTOC medische techniek B.V · Class I
- MIRABOR-CA (12 BURS)- — Hager Worldwide, Inc. · Class I
- ZOCCOLI BIANCHI - con fori - 37 — GIMA SPA · Class I
- 4CIS® INSTRUMENT SYSTEM — ALPHANOX CO., LTD. · Class I
Cleared under the same submission
K193554 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medartis Inc.
Sources (1)
- FDA UDI 6c13a328-3a4b-4b6b-91a5-5a740bf7f281 35 fields · synced Jun 1, 2026