Angio Dynamics 10601009

GUDID 00850015378669

Duel Fenestrated Drape Sterile

EXACT MEDICAL MANUFACTURING, INC.

Patient surgical drape, single-use, sterile Patient surgical drape, single-use, sterile Patient surgical drape, single-use, sterile
Primary Device ID00850015378669
NIH Device Record Keya2223391-ac09-4345-88c3-c52aaa730bb4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAngio Dynamics
Version Model Number10601009
Catalog Number10601009
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
GS100850015378652 [Primary]
GS100850015378652 [Primary]
GS100850015378652 [Primary]
GS100850015378669 [Package]
Contains: 00850015378652
Package: case [24 Units]
In Commercial Distribution
GS100850015378669 [Package]
Contains: 00850015378652
Package: case [24 Units]
In Commercial Distribution
GS100850015378669 [Package]
Contains: 00850015378652
Package: case [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KKXDrape, Surgical
KKXDrape, Surgical
KKXDrape, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-19
Device Publish Date2020-05-11

On-Brand Devices [Angio Dynamics]

00850015378669Duel Fenestrated Drape Sterile
00850015378645Towel Disposable Sterile Blue

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