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U-Bar Proximal

FDA UDI

Class I (US FDA UDI)

by Charmant Inc.

Identity

Trade Name
U-Bar Proximal FDA UDI
Generic Name
Surgical instrument assist arm system structural component FDA UDI
Model / Reference
31-5142UP FDA UDI

Identifiers

Primary DI / UDI-DI
00883475954661 FDA UDI
FDA Product Code
HBM FDA UDI
GMDN Term
Surgical instrument assist arm system structural component FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
882.4440 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

No

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical instrument assist arm system structural component

U-Bar Proximal by Charmant Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical instrument assist arm system structural component.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Charmant Inc.

Sources (1)

  • FDA UDI 700d9749-1bb8-44f8-980c-0861dae6e4ba 32 fields · synced May 30, 2026