Home GUDID 00815849023352 Custom Medical Specialties
Primary DI 00815849023352
Brand Custom Medical Specialties
Company CUSTOM ASSEMBLIES, INC.
Model CMS-6013
Device description Film Reinforced XXL Gown - Sterile
Published 2020-09-30
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name PUI Drape, Surgical, Exempt
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PUI Drape, Surgical, Exempt General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00815849023352 Package GS1 20 In Commercial Distribution 00815849023345 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00815849023352 00815849023352 815849023352 0815849023352 00815849023345 00815849023345 815849023345 0815849023345
GMDN Terms# Term, Definition table Term Definition Patient surgical drape, single-use, sterile A sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to isolate a specific anatomical site (e.g., site of surgical incision) from potential contamination (e.g., microbial, substance). The device may also be used to protect a patient from heat/flame during a surgical procedure, however it is not designed with specific heat-reflective or laser resistant materials. This is a single-use device.
Regulatory Flags# DUNS number 948904735 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00815849020917 Custom Medical Specialties, Inc. CMS-987 2026-10-06 00815849022768 Custom Medical Specialties, Inc. CMS-907 2026-10-06 00815849022775 Custom Medical Specialties, Inc. CMS-910V 2026-10-06 00815849022782 Custom Medical Specialties, Inc. CMS-912V 2026-10-06 00815849022836 Custom Medical Specialties, Inc. CMS-919VT 2026-10-06 00815849025288 Custom Medical Specialties, Inc. CMS-300 2026-10-06 00815849025363 Custom Medical Specialties, Inc. CMS-2010 2026-10-06 00815849025493 Custom Medical Specialties, Inc. CMS-954V-6 2026-10-06 00815849025615 Custom Medical Specialties, Inc. CMS-909 2026-10-06 00815849025844 Custom Medical Specialties, Inc. CMS-942V 2026-10-06 00815849020160 Custom Medical Specialties, Inc. CMS-510 2016-11-21 00815849020177 Custom Medical Specialties, Inc. CMS-515 2016-11-21 00815849020108 Custom Medical Specialties, Inc. CMS-1637 2016-11-21 00815849021556 Custom Medical Specialties, Inc. CMS-1637-NS 2016-11-21 00815849021839 Custom Medical Specialties, Inc. CMS-586 2016-11-21 00815849024021 Custom Medical Specialties, Inc. CMS-2732-R4 2023-09-14 00815849024571 Custom Medical Specialties, Inc. CMS-6314-R6 2023-09-14 00815849023369 Custom Medical Specialties, Inc. CMS-1235 2023-09-13 00815849023390 Custom Medical Specialties, Inc. CMS-1238 2023-09-13 00815849023406 PG-1000 PG-1000 2023-09-13
Other Devices Sharing Product Codes#