Exact Medical Manufacturing Inc. E100350

GUDID 00850015378140

Large Poly-reinforced Surgical Gown


Surgical gown, single-use
Primary Device ID00850015378140
NIH Device Record Keyb2201b2c-f196-4d60-b207-c802aad33605
Commercial Distribution StatusIn Commercial Distribution
Brand NameExact Medical Manufacturing Inc.
Version Model NumberE100350
Catalog NumberE100350
Company DUNS014464314
Device Count1
DM Exempttrue
Pre-market Exemptfalse
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850015378133 [Primary]
GS100850015378140 [Package]
Contains: 00850015378133
Package: Case [36 Units]
In Commercial Distribution

FDA Product Code

FYAGown, Surgical


Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-11
Device Publish Date2020-02-03

On-Brand Devices [Exact Medical Manufacturing Inc.]

00850015378188XXL Poly-reinforced Surgical Gown
00850015378164XL Poly-reinforced Surgical Gown
00850015378140Large Poly-reinforced Surgical Gown
00850015378102XL Fabric Reinforced Surgical Gown
00850015378089Large Fabric Reinforced Surgical Gown
00850015378065XXL AAMI 3 Non-Reinforced Surgical Gowns
00850015378041XL AAMI 3 Non-Reinforced Surgical Gown
00850015378027Large AAMI 3 Non-Reinforced Surgical Gown

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