Custom Medical Specialties

GUDID 00815849023352

Film Reinforced XXL Gown - Sterile

CUSTOM ASSEMBLIES, INC.

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Primary Device ID00815849023352
NIH Device Record Keyd9cd4a37-9b68-40c5-a089-54b56f40d2f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameCustom Medical Specialties
Version Model NumberCMS-6013
Company DUNS948904735
Company NameCUSTOM ASSEMBLIES, INC.
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815849023345 [Primary]
GS100815849023352 [Package]
Contains: 00815849023345
Package: [20 Units]
In Commercial Distribution

FDA Product Code

PUIDrape, Surgical, Exempt

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-08
Device Publish Date2020-09-30

On-Brand Devices [Custom Medical Specialties]

0081584902305572" Drainage Hose - Sterile
00815849023277Large Bore Infiltration Set - Sterile
0081584902329120" LS Extension Set - Sterile
00815849023352Film Reinforced XXL Gown - Sterile

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