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X-Pac

FDA UDI

Class I (US FDA UDI)

by Expanding Innovations, Inc.

Identity

Trade Name
X-PAC FDA UDI
Generic Name
Open-surgery dissector FDA UDI
Device Name
Penfield, Push/Pull, #4, Long FDA UDI
Model / Reference
EI3921 FDA UDI
Description
Penfield, Push/Pull, #4, Long FDA UDI

Identifiers

Primary DI / UDI-DI
00810166521550 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Open-surgery dissector FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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

Yes

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

Category: Open-surgery dissector

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

Similar devices

Also classified as Open-surgery dissector.

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 bf419291-15ae-4f3f-a04e-8f37cf535953 34 fields · synced May 30, 2026