MAMMOGRAPHY ROBE 74340081

GUDID 00634916494099

MAMMOGRAPHY ROBE, Pink, OSFA, Microfiber Front Opening (KO115)

STANDARD TEXTILE CO., INC.

Patient gown, reusable

• Primary Device ID: 00634916494099
• NIH Device Record Key: 1e55e375-1b72-4124-9513-b454b2ae23c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAMMOGRAPHY ROBE
• Version Model Number: 74340081
• Catalog Number: 74340081
• Company DUNS: 006999858
• Company Name: STANDARD TEXTILE CO., INC.
• Device Count: 24
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634916494099 [Primary]
GS1	10634916494096 [Unit of Use]

FDA Product Code

• FME: Gown, Examination

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-13
• Device Publish Date: 2020-04-03

Devices Manufactured by STANDARD TEXTILE CO., INC.

• 00634916019353 - Standard Supreme: 2026-03-19 Instrument Drape, 2 Ply Standard Supreme, 5% COTTON, 45% POLYESTER
• 00634916099225 - INSTRUMENT COVER: 2026-03-19 Instrument Cover, 2 Ply T-180, 55% Cotton, 45% Polyester
• 00634916120905 - Instrument Holder: 2026-03-19 Wrappel Instrument Holder with Pockets, 100% Polyester
• 00634916349740 - Compel MLR OR Gown: 2026-03-19 Compel MLR OR Gown, Snap Closures at Neck, 100% POLYESTER.
• 00634916781373 - WrapPel Table Cover: 2026-03-19 WrapPel Table Cover with Pad (1 Ply), 100% POLYESTER'
• 00634916788105 - Compel MLR OR Gown: 2026-03-19 Compel MLR OR Gown 2-Ply Front/Sleeves, Tie, 100% POLYESTER.
• 00634916788112 - Compel MLR OR Gown: 2026-03-19 Compel MLR OR Gown 2-Ply Front/Sleeves, Tie, 100% POLYESTER.
• 00634916788129 - Compel MLR OR Gown: 2026-03-19 Compel MLR OR Gown, 2-Ply Front/Sleeves, Tie 100% POLYESTER