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rexpander

FDA UDI

Class I (US FDA UDI)

by Rex Implants, Inc

Identity

Trade Name
rexpander FDA UDI
Generic Name
Maxillofacial bone separator FDA UDI
Device Name
rexpander 2.4 x 9 FDA UDI
Model / Reference
2.4 x 9 FDA UDI
Description
rexpander 2.4 x 9 FDA UDI

Identifiers

Catalog Number
BE-09 FDA UDI
Primary DI / UDI-DI
D894BE090 FDA UDI
FDA Product Code
DZN FDA UDI
GMDN Term
Maxillofacial bone separator FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4565 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

No

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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Height — 9 Millimeter FDA UDI
Width — 2.4 Millimeter FDA UDI

Category: Maxillofacial bone separator

rexpander by Rex Implants, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Maxillofacial bone separator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Rex Implants, Inc

Sources (1)

  • FDA UDI a84fd9b4-6285-414d-b00e-afcb1965e789 36 fields · synced May 30, 2026