RMAC Surgical

Basic Information

• Brand Name: RMAC Surgical
• Primary DI: 00754027700695
• Version / Model: STA01
• Company Name: RMAC Surgical, Inc
• Labeler DUNS: 203768551
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-25
• Public Version: 2
• Public Version Date: 2025-05-15
• Public Version Status: Update
• Public Device Record Key: e68a970a-9e67-43b8-988e-fd2ba7a51214

Device Description

Kidney Tag (2-label set)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYV	Label Or Tag, Sterile	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62002	Laboratory specimen/material barcode label	A label (e.g., a card or insert) featuring a barcode intended to facilitate clear and easy identification of a laboratory specimen and/or material (e.g., a clinical specimen or assay reagent/buffer in a container). It is electronically readable using a computerized reader or scanner, either on-board or connected to an instrument or analyser. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10754027700692	GS1	Case	100	Not in Commercial Distribution	2025-05-14
Primary	00754027700695	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]