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X-Pac

FDA UDI

Class II (US FDA UDI)

by Expanding Innovations, Inc.

Identity

Trade Name
X-PAC FDA UDI
Generic Name
Instrument tray, reusable FDA UDI
Device Name
X-PAC Lateral General Implant Caddy FDA UDI
Model / Reference
EI3047 FDA UDI
Description
X-PAC Lateral General Implant Caddy FDA UDI

Identifiers

Primary DI / UDI-DI
00850041805351 FDA UDI
510(k) Number
K223174 FDA UDI
FDA Product Code
KCT FDA UDI
GMDN Term
Instrument tray, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6850 FDA UDI
Commercial Distribution
Not 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

X-Pac by Expanding Innovations, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K223174 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Expanding Innovations, Inc.

Sources (1)

  • FDA UDI f483bb5c-0c20-430a-8646-cce799bac0b2 35 fields · synced Jun 8, 2026