AVID TruCustom

GUDID 20809160067458

AVID MEDICAL, INC.

Patient surgical drape, single-use
Primary Device ID20809160067458
NIH Device Record Keya3f060e6-4736-451c-8694-60813b3c6837
Commercial Distribution StatusIn Commercial Distribution
Brand NameAVID TruCustom
Version Model NumberPC01316_0005
Company DUNS015623119
Company NameAVID MEDICAL, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110809160067451 [Primary]
GS120809160067458 [Package]
Contains: 10809160067451
Package: [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQXWIRE, GUIDE, CATHETER

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20809160067458]

Ethylene Oxide


[20809160067458]

Ethylene Oxide


[20809160067458]

Ethylene Oxide


[20809160067458]

Ethylene Oxide


[20809160067458]

Ethylene Oxide


[20809160067458]

Ethylene Oxide


[20809160067458]

Ethylene Oxide


[20809160067458]

Ethylene Oxide


[20809160067458]

Ethylene Oxide


[20809160067458]

Ethylene Oxide


[20809160067458]

Ethylene Oxide


[20809160067458]

Ethylene Oxide


[20809160067458]

Ethylene Oxide


[20809160067458]

Ethylene Oxide


[20809160067458]

Ethylene Oxide


[20809160067458]

Ethylene Oxide


[20809160067458]

Ethylene Oxide


[20809160067458]

Ethylene Oxide


[20809160067458]

Ethylene Oxide


[20809160067458]

Ethylene Oxide


[20809160067458]

Ethylene Oxide


[20809160067458]

Ethylene Oxide


[20809160067458]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-02-05
Device Publish Date2016-09-15

On-Brand Devices [AVID TruCustom]

20809160232016ROXS001-01_0004
20809160232009AXOG7000-01_0007
20809160231996ADVH067-17_0003
20809160231989GRAN014-06_0001
20809160231972LIFE0078-03_0006
20809160232085NWHR011-01_0006
20809160232078JNTH001-05_0007
20809160232061GRAN014-06_0003
20809160232054CMRL002-02_0001
20809160232047CMRL001-02_0001
20809160232030SMHS011-07_0002
20809160232023ADVH067-17_0001
20809160232238LIFP016-03_0002
20809160232221LIFP004-11_0003
20809160232214LIFP001-07_0002
20809160232207HSAM006-12_0012
20809160232191SINA251_0003
20809160232184HSAM035-05_0013
20809160232177BTMF015-03_0001
20809160232160MAMC236-12_0008
20809160232153RMRI021-25_0010
20809160232146LANC034-18_0001
20809160232139RMRI042-12_0003
20809160232122KAFB006-11_0007
20809160232115CMRL002-02_0004
20809160232269PMHP005-02_0015
20809160232252ADVC087-23_0002
20809160232535NAFB079-01_0003
10809160232521AVMD031_0014
20809160232290SSSC002-03_0006
20809160232283PMHP004-05_0002
20809160232627NHRM002-01_0005
20809160232610LIFP017-04_0002
20809160232603CHWE016-02_0002
20809160232597ADVM039-07_0003
20809160232580CHWE001-02_0002
20809160232573ADBR017-12_0003
20809160232566ADVM022-19_0004
20809160233372VAST038-02_0004
20809160233365VAST031-03_0003
20809160233358VANW025-03_0003
10809160233344VANW011-04_0003
20809160233334VAMH003-01_0003
10809160233320VAHT026-10_0003
10809160233313GVVA010-05_0003
10809160233306GVVA004-06_0003
20809160233297VAST026-08_0003
20809160233280VAST018-07_0003
20809160233273VAST017-06_0003
20809160233266VAST016-07_0003

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