SURGICAL APPAREL ACCESSORY

GUDID 06950471300069

SURGICAL APPAREL ACCESSORY, PROTECT THE WEARER FROM THE SPREAD OF INFECTION OR ILLNESS, CREATING A BARRIER AGAINST POTENTIALLY INFECTIOUS

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

Public face mask, single-use
Primary Device ID06950471300069
NIH Device Record Key547cbdba-6207-46c9-abd2-c9132fd4c6e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSURGICAL APPAREL ACCESSORY
Version Model Number28023
Company DUNS547874292
Company NameHangzhou A-Tek Medical & Textiles Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106950471300069 [Primary]

FDA Product Code

LYUAccessory, Surgical Apparel

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-26
Device Publish Date2023-07-18

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

06950471300137 - DISPOSABLE HOT OR COLD PACK COVER2023-07-31 DISPOSABLE HOT OR COLD PACK COVER, USED TO COVER THE ICE PACK OR HOT PACK
06950471300144 - VACUUM COLLECTION BOTTLE2023-07-31 VACUUM COLLECTION BOTTLE, COLLECT LARGER VOLUMES OF FLUID FROM PROCEDURES
06950471300151 - GAS COLLECTING VESSEL2023-07-31 GAS COLLECTING VESSEL, COLLECT AND STORE GAS SAMPLES OR LOW PRESSURE GAS STREAMS
06950471300038 - DISPOSABLE BEDDING PRODUCTS2023-07-26 MEDICAL DISPOSABLE BEDDING, PROTECT BEDDING FROM GETTING STAINED DURING USE, PROTECT PATIENT FROM CROSS-INFECTION CAUSED BY BEDD
06950471300045 - EXAMINATION GOWN2023-07-26 EXAMINATION GOWN, PROTECT THE WEARER FROM THE SPREAD OF INFECTION OR ILLNESS, CREATING A BARRIER AGAINST POTENTIALLY INFECTIOUS
06950471300052 - SURGICAL CAP2023-07-26 SURGICAL CAP, HEADWEAR FOR SURGEONS TO WEAR IN OPERATING ROOMS TO PREVENT CONTAMINATION OF THE STERILE AREA
06950471300069 - SURGICAL APPAREL ACCESSORY2023-07-26SURGICAL APPAREL ACCESSORY, PROTECT THE WEARER FROM THE SPREAD OF INFECTION OR ILLNESS, CREATING A BARRIER AGAINST POTENTIALLY INFECTIOUS
06950471300069 - SURGICAL APPAREL ACCESSORY2023-07-26 SURGICAL APPAREL ACCESSORY, PROTECT THE WEARER FROM THE SPREAD OF INFECTION OR ILLNESS, CREATING A BARRIER AGAINST POTENTIALLY I
06950471300076 - OPERATING-ROOM SHOE COVER2023-07-26 OPERATING-ROOM SHOE COVER, PROTECT WORKSHOES FROM ACCIDENTAL BLOOD OR BODY FLUID SPILLS IN THE OR

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