AngioSystems Drape

GUDID 00816611021453

ANGIOSYSTEMS, INCORPORATED

Patient surgical drape, single-use, sterile
Primary Device ID00816611021453
NIH Device Record Keyc3ba760e-fcfb-4259-bb42-2d192afaa674
Commercial Distribution StatusIn Commercial Distribution
Brand NameAngioSystems Drape
Version Model Number3409
Company DUNS144884467
Company NameANGIOSYSTEMS, INCORPORATED
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816611020197 [Primary]
GS100816611021453 [Package]
Contains: 00816611020197
Package: [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KKXDrape, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-08
Device Publish Date2016-06-15

On-Brand Devices [AngioSystems Drape]

00816611021919260-12
008166110251093631-10
008166110250003606-1
008166110229935520
008166110229555073
008166110229315061
008166110229175020
008166110228943425-10
008166110228709266
008166110228569265-1
008166110228323671
008166110228183528
008166110219723060-08
00816611021958RS1000
00816611021941ASD2111
008166110218979009-01NS
008166110218733606
00816611021859DR5-18063NS
00816611021842ASD3330-1
008166110218359360NS
008166110218049229-03NS
008166110217819061NS
008166110215763606NS
008166110215383434NS
008166110214603422NS
008166110214463400NS
008166110214393241NS
008166110214223236NS
008166110214153215NS
008166110212623003-45NS
008166110211493001NS
00816611021132060-1722A
00816611021101KBD0231
00816611021095060-1711A
00816611021071KBD2545-4NS
00816611020999KBD0700
008166110218289260-15
008166110218119260-10
008166110217989228-1
008166110217679009-01
008166110217123904-10
008166110217053902-1
008166110216753665-1
008166110216683663-01
008166110216443648-03
008166110216203631-03
008166110216063627-01
008166110215903616-03
008166110215833609-01
008166110215143432-02S

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