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.

00850015378331 - Exact Medical Manufacturing Inc2024-07-25 Bronchoscope Storage Cover 8x80cm with tape closure
00850015378355 - Exact Medical Manufacturing Inc2024-07-25 Bronchoscope Storage Cover 12x100cm with tape closure
00850015378386 - Exact Medical Manufacturing Inc2024-07-25 Bronchoscope Storage Cover 8x120cm with tape closure
00850015378416 - Exact Medical Manufacturing Inc2024-07-25 Bronchoscope Storage Cover 8x100cm with tape closure
00850015378447 - Exact Medical Manufacturing Inc2024-07-25 Bronchoscope Storage Cover 20x110cm with tape closure
00850015378478 - Exact Medical Manufacturing Inc2024-07-25 Bronchoscope Storage Cover 8x90cm with tape closure
00850015378591 - Exact Medical Manufacturing Inc2024-07-25 Bronchoscope Storage Cover 8x80cm with tape closure
00850024023666 - Exact Medical2024-07-25 Band Bag with tape 122x65cm - 48"x26"

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