Identity
- Trade Name
- Aptimax FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Instrument Tray 278 mm x 270 mm x 100 mm (11 in x 10-5/8 in x 4 in) FDA UDI
- Model / Reference
- 13836 FDA UDI
- Description
- Instrument Tray 278 mm x 270 mm x 100 mm (11 in x 10-5/8 in x 4 in) FDA UDI
Identifiers
- Catalog Number
- 13836 FDA UDI
- Primary DI / UDI-DI
- 10705037016112 FDA UDI
- 510(k) Number
- K013003 FDA UDI
- FDA Product Code
- FRG FDA UDI
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6850 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
No
FDA UDI
Over-the-Counter
Yes
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
Category: Instrument tray, reusable
Aptimax by Advanced Sterilization Products Services Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Instrument tray, reusable.
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- Instrument Case — Katena Products, Inc. · Class I
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- SHEFFIELD RING FIXATOR — Orthofix, Inc. · Class II
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- ASELTECH — Asel Tibbi Aletler A.S. · Class I
Cleared under the same submission
K013003 also covers:
- 100NX DUO Upgrade Kit with VELOCITY — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Aptimax — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Aptimax — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Aptimax — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Aptimax — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Aptimax — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Aptimax — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Aptimax — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Aptimax — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Aptimax — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Aptimax — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Aptimax — ADVANCED STERILIZATION PRODUCTS SERVICES 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
- Advanced Sterilization Products Services Inc.
Sources (1)
- FDA UDI 3a623466-84a2-43f1-8e57-27b477b5021e 37 fields · synced May 30, 2026