Artromed AM3008

GUDID 16975085709425

Camera Drape, Closed System Coupler & Ring Applicator, 6"x98"

EXACT MEDICAL MANUFACTURING, INC.

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Primary Device ID16975085709425
NIH Device Record Keyf6f07603-9df0-4dea-9837-956d8937bb92
Commercial Distribution StatusIn Commercial Distribution
Brand NameArtromed
Version Model NumberAM3008
Catalog NumberAM3008
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 Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106975085709428 [Primary]
GS116975085709425 [Package]
Contains: 06975085709428
Package: Case [32 Units]
In Commercial Distribution
GS126975085709422 [Package]
Package: Case [2 Units]
In Commercial Distribution

FDA Product Code

KKXDrape, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-12
Device Publish Date2023-04-04

On-Brand Devices [Artromed]

16975085709111Camera Drape, Blue Elasticized Tip 18x244cm
16975085709104CAK XI, C1 Clip Drape 86", 2 band 36x36", FSC
16975085709425Camera Drape, Closed System Coupler & Ring Applicator, 6"x98"

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