Identity
- Trade Name
- X-PAC FDA UDI
- Generic Name
- Arthroscopic access cannula, reusable FDA UDI
- Device Name
- 12mm Cage Cannula FDA UDI
- Model / Reference
- EI2452 FDA UDI
- Description
- 12mm Cage Cannula FDA UDI
Identifiers
- Catalog Number
- EI2452 FDA UDI
- Primary DI / UDI-DI
- 00850001720052 FDA UDI
- 510(k) Number
- K160856 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Arthroscopic access cannula, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 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
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Arthroscopic access cannula, reusable
X-Pac by Expanding Innovations, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Arthroscopic access cannula, reusable.
- Arthrex® — Arthrex, Inc. · Class I
- INFLOW CANNULA SET — SONTEC INSTRUMENTS, INC. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- INFLOW CANNULA SET — SONTEC INSTRUMENTS, INC. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- OBTURATOR — SONTEC INSTRUMENTS, INC. · Class I
Cleared under the same submission
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
- Expanding Innovations, Inc.
Sources (1)
- FDA UDI 6c9ac8d8-c9b0-4e8c-a417-e4e86565f7f6 36 fields · synced May 30, 2026