Customed 9004823

GUDID 10850003355129

Probe Cover, PE, Elastic bands 15x244cm - 6"x96"

EXACT MEDICAL MANUFACTURING, INC.

Medical equipment drape, single-use
Primary Device ID10850003355129
NIH Device Record Keyc343febe-bebb-49aa-a455-aac9fe4fa921
Commercial Distribution StatusIn Commercial Distribution
Brand NameCustomed
Version Model Number9004823
Catalog Number9004823
Company DUNS014464314
Company NameEXACT MEDICAL MANUFACTURING, INC.
Device Count1
DM Exemptfalse
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 Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100850003355122 [Primary]
GS110850003355129 [Package]
Contains: 00850003355122
Package: case [60 Units]
In Commercial Distribution

FDA Product Code

KKXDrape, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-06
Device Publish Date2019-01-09

On-Brand Devices [Customed]

10850003355150Probe Cover, PE, Gel and Elastic bands 15x244cm - 6"x96"
10850003355143C-Arm Drape 104x188cm - 41"x74"
10850003355136C-Arm Drape 104x163cm - 41"x64"
10850003355129Probe Cover, PE, Elastic bands 15x244cm - 6"x96"
10850003355112Camera Drape, Blue Elastic Tip, 23x244cm - 9"x96"
00850003355108Microscope Drape, Zeiss MD, 137x381cm - 54"x150"
008500033550859004820
10850003355075Band Bag with tape 102x102cm - 40"x40"
00850003355061Microscope Drape, Leica, 104x267cm - 41x105"
00850003355986Probe Cover, PE, Gel and Elastic bands 15x244cm, 6"x96"
00850015378218Microscope Drape- Leica 137x305cm - 54"x120"

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