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RMAC Surgical

FDA UDI

Class I (US FDA UDI)

by RMAC Surgical, Inc

Identity

Trade Name
RMAC Surgical FDA UDI
Generic Name
Laboratory specimen/material barcode label FDA UDI
Device Name
Kidney Tag (2-label set) FDA UDI
Model / Reference
STA01 FDA UDI
Description
Kidney Tag (2-label set) FDA UDI

Identifiers

Primary DI / UDI-DI
00754027700695 FDA UDI
FDA Product Code
LYV FDA UDI
GMDN Term
Laboratory specimen/material barcode label FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Laboratory specimen/material barcode label

RMAC Surgical by RMAC Surgical, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laboratory specimen/material barcode label.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
RMAC Surgical, Inc

Sources (1)

  • FDA UDI e68a970a-9e67-43b8-988e-fd2ba7a51214 34 fields · synced Jun 8, 2026