Identity
- Trade Name
- X-PAC FDA UDI
- Generic Name
- Surgical instrument interim-placement holder, reusable FDA UDI
- Device Name
- X-PAC Lateral Plate Instruments and Implants Case FDA UDI
- Model / Reference
- EI3200 FDA UDI
- Description
- X-PAC Lateral Plate Instruments and Implants Case FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850041805542 FDA UDI
- 510(k) Number
- K250602 FDA UDI
- FDA Product Code
- KCT FDA UDI
- GMDN Term
- Surgical instrument interim-placement holder, 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical instrument interim-placement holder, reusable
X-Pac by Expanding Innovations, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument interim-placement holder, reusable.
- Sklar® — Sklar Corporation · Class I
- LANDANGER — LANDANGER · Class I
- HNM MEDICAL — HNM STAINLESS, LLC. · Class I
- Reicodent — devemed GmbH · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- HNM MEDICAL — HNM STAINLESS, LLC. · Class I
- C-Guide-Large — VERSAH, LLC · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
Cleared under the same submission
K250602 also covers:
- X-PAC — Expanding Innovations, Inc.
- X-PAC — Expanding Innovations, Inc.
- X-PAC — Expanding Innovations, Inc.
- X-PAC — Expanding Innovations, Inc.
- X-PAC — Expanding Innovations, Inc.
- X-PAC — Expanding Innovations, Inc.
- X-PAC — Expanding Innovations, Inc.
- X-PAC — Expanding Innovations, Inc.
- X-PAC — Expanding Innovations, Inc.
- X-PAC — Expanding Innovations, Inc.
- X-PAC — Expanding Innovations, Inc.
- X-PAC — Expanding Innovations, 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
- Expanding Innovations, Inc.
Sources (1)
- FDA UDI 1a9e1108-9441-43ad-9b54-8a772f36504d 35 fields · synced Jun 6, 2026