Exact Medical Medical Inc. E105270

GUDID 00850015378126

XXL Fabric Reinforced Surgical Gowns

EXACT MEDICAL MANUFACTURING, INC.

Surgical gown, single-use
Primary Device ID00850015378126
NIH Device Record Keye5c10516-7ec3-4b6b-a1dc-c65c53999562
Commercial Distribution StatusIn Commercial Distribution
Brand NameExact Medical Medical Inc.
Version Model NumberE105270
Catalog NumberE105270
Company DUNS014464314
Company NameEXACT MEDICAL MANUFACTURING, INC.
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
GS100850015378119 [Primary]
GS100850015378126 [Package]
Contains: 00850015378119
Package: Case [28 Units]
In Commercial Distribution

FDA Product Code

FYAGown, Surgical

Sterilization

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

Devices Manufactured by EXACT MEDICAL MANUFACTURING, INC.

00850015378188 - Exact Medical Manufacturing Inc.2020-02-11 XXL Poly-reinforced Surgical Gown
00850015378164 - Exact Medical Manufacturing Inc.2020-02-11 XL Poly-reinforced Surgical Gown
00850015378140 - Exact Medical Manufacturing Inc.2020-02-11 Large Poly-reinforced Surgical Gown
00850015378126 - Exact Medical Medical Inc.2020-02-11XXL Fabric Reinforced Surgical Gowns
00850015378126 - Exact Medical Medical Inc.2020-02-11 XXL Fabric Reinforced Surgical Gowns
00850015378102 - Exact Medical Manufacturing Inc.2020-02-11 XL Fabric Reinforced Surgical Gown
00850015378089 - Exact Medical Manufacturing Inc.2020-02-11 Large Fabric Reinforced Surgical Gown
00850015378065 - Exact Medical Manufacturing Inc.2020-02-11 XXL AAMI 3 Non-Reinforced Surgical Gowns
00850015378041 - Exact Medical Manufacturing Inc.2020-02-11 XL AAMI 3 Non-Reinforced Surgical Gown

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