AngioSystems Sharp Cup

GUDID 00816611020050

ANGIOSYSTEMS, INCORPORATED

Surgical drape clip
Primary Device ID00816611020050
NIH Device Record Key6c99adb1-f6b7-4a24-862e-978ec9657eea
Commercial Distribution StatusIn Commercial Distribution
Brand NameAngioSystems Sharp Cup
Version Model Number1036
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
GS100816611020029 [Primary]
GS100816611020050 [Package]
Contains: 00816611020029
Package: [12 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 Number3
Public Version Date2018-07-06
Device Publish Date2016-06-15

Devices Manufactured by ANGIOSYSTEMS, INCORPORATED

00816611025925 - Angiosystems inc2024-10-03
00816611025871 - AngioSystems Tray2023-12-05
00816611025895 - AngioSystems Tray2023-12-05
00816611025819 - AngioSystems Tray2022-08-31
00816611025833 - AngioSystems Tray2022-08-31
00816611025802 - AngioSystems Drape2022-06-01
00816611029992 - AngioSystems Tray2022-04-08
10816611025755 - AngioSystems Tray2022-01-28

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