OPERATING-ROOM SHOE COVER

GUDID 06950471300076

OPERATING-ROOM SHOE COVER, PROTECT WORKSHOES FROM ACCIDENTAL BLOOD OR BODY FLUID SPILLS IN THE OR

Hangzhou A-Tek Medical & Textiles Co., Ltd.

Medical shoe

• Primary Device ID: 06950471300076
• NIH Device Record Key: c0d1077d-4a54-4e59-ac50-bb8a4fdbd6fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPERATING-ROOM SHOE COVER
• Version Model Number: 28024
• Company DUNS: 547874292
• Company Name: Hangzhou A-Tek Medical & Textiles Co., Ltd.
• Device Count: 1
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06950471300076 [Primary]

FDA Product Code

• BWP: Shoe And Shoe Cover, Conductive

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: 2023-07-26
• Device Publish Date: 2023-07-18

Devices Manufactured by Hangzhou A-Tek Medical & Textiles Co., Ltd.

• 06950471300137 - DISPOSABLE HOT OR COLD PACK COVER: 2023-07-31 DISPOSABLE HOT OR COLD PACK COVER, USED TO COVER THE ICE PACK OR HOT PACK
• 06950471300144 - VACUUM COLLECTION BOTTLE: 2023-07-31 VACUUM COLLECTION BOTTLE, COLLECT LARGER VOLUMES OF FLUID FROM PROCEDURES
• 06950471300151 - GAS COLLECTING VESSEL: 2023-07-31 GAS COLLECTING VESSEL, COLLECT AND STORE GAS SAMPLES OR LOW PRESSURE GAS STREAMS
• 06950471300038 - DISPOSABLE BEDDING PRODUCTS: 2023-07-26 MEDICAL DISPOSABLE BEDDING, PROTECT BEDDING FROM GETTING STAINED DURING USE, PROTECT PATIENT FROM CROSS-INFECTION CAUSED BY BEDD
• 06950471300045 - EXAMINATION GOWN: 2023-07-26 EXAMINATION GOWN, PROTECT THE WEARER FROM THE SPREAD OF INFECTION OR ILLNESS, CREATING A BARRIER AGAINST POTENTIALLY INFECTIOUS
• 06950471300052 - SURGICAL CAP: 2023-07-26 SURGICAL CAP, HEADWEAR FOR SURGEONS TO WEAR IN OPERATING ROOMS TO PREVENT CONTAMINATION OF THE STERILE AREA
• 06950471300069 - SURGICAL APPAREL ACCESSORY: 2023-07-26 SURGICAL APPAREL ACCESSORY, PROTECT THE WEARER FROM THE SPREAD OF INFECTION OR ILLNESS, CREATING A BARRIER AGAINST POTENTIALLY I
• 06950471300076 - OPERATING-ROOM SHOE COVER: 2023-07-26OPERATING-ROOM SHOE COVER, PROTECT WORKSHOES FROM ACCIDENTAL BLOOD OR BODY FLUID SPILLS IN THE OR
• 06950471300076 - OPERATING-ROOM SHOE COVER: 2023-07-26 OPERATING-ROOM SHOE COVER, PROTECT WORKSHOES FROM ACCIDENTAL BLOOD OR BODY FLUID SPILLS IN THE OR