DePuy Synthes VELYS 4515-70-009

GUDID 00748426124909

VELYS Satellite Station Drape_EO_20CS

Microtek Medical Inc.

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Primary Device ID00748426124909
NIH Device Record Keyaf60eb74-1426-4189-8823-c517d77cb078
Commercial Distribution StatusIn Commercial Distribution
Brand NameDePuy Synthes VELYS
Version Model Number451570009
Catalog Number4515-70-009
Company DUNS106908437
Company NameMicrotek Medical Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100748426124909 [Primary]
GS150748426124904 [Package]
Package: [20 Units]
In Commercial Distribution

FDA Product Code

PUIDrape, Surgical, Exempt

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00748426124909]

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[00748426124909]

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[00748426124909]

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[00748426124909]

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[00748426124909]

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[00748426124909]

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[00748426124909]

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[00748426124909]

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[00748426124909]

Ethylene Oxide


[00748426124909]

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[00748426124909]

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[00748426124909]

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[00748426124909]

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[00748426124909]

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[00748426124909]

Ethylene Oxide


[00748426124909]

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[00748426124909]

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[00748426124909]

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[00748426124909]

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[00748426124909]

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[00748426124909]

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[00748426124909]

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[00748426124909]

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[00748426124909]

Ethylene Oxide


[00748426124909]

Ethylene Oxide


[00748426124909]

Ethylene Oxide


[00748426124909]

Ethylene Oxide


[00748426124909]

Ethylene Oxide


[00748426124909]

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[00748426124909]

Ethylene Oxide


[00748426124909]

Ethylene Oxide


[00748426124909]

Ethylene Oxide


[00748426124909]

Ethylene Oxide


[00748426124909]

Ethylene Oxide


[00748426124909]

Ethylene Oxide


[00748426124909]

Ethylene Oxide


[00748426124909]

Ethylene Oxide


[00748426124909]

Ethylene Oxide


[00748426124909]

Ethylene Oxide


[00748426124909]

Ethylene Oxide


[00748426124909]

Ethylene Oxide


[00748426124909]

Ethylene Oxide


[00748426124909]

Ethylene Oxide


[00748426124909]

Ethylene Oxide


[00748426124909]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-09
Device Publish Date2021-04-01

On-Brand Devices [DePuy Synthes VELYS]

00748426124909VELYS Satellite Station Drape_EO_20CS
00748426124886VELYS Device Sterile Drape_EO_20CS
50748426130110VELYS™ Satellite Station Drape
00748426130092VELYS Device Sterile Drape

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