GUDID 10849296005606

WELMED INC.

Patient surgical drape, single-use, sterile
Primary Device ID10849296005606
NIH Device Record Key317b6073-64bd-4f55-ba63-4bdfb63c81a9
Commercial Distribution StatusIn Commercial Distribution
Version Model Number280-012
Company DUNS828213426
Company NameWELMED 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-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100849296005609 [Primary]
GS110849296005606 [Package]
Contains: 00849296005609
Package: [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KKXDrape, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10849296005606]

Ethylene Oxide


[10849296005606]

Ethylene Oxide


[10849296005606]

Ethylene Oxide


[10849296005606]

Ethylene Oxide


[10849296005606]

Ethylene Oxide


[10849296005606]

Ethylene Oxide


[10849296005606]

Ethylene Oxide


[10849296005606]

Ethylene Oxide


[10849296005606]

Ethylene Oxide


[10849296005606]

Ethylene Oxide


[10849296005606]

Ethylene Oxide


[10849296005606]

Ethylene Oxide


[10849296005606]

Ethylene Oxide


[10849296005606]

Ethylene Oxide


[10849296005606]

Ethylene Oxide


[10849296005606]

Ethylene Oxide


[10849296005606]

Ethylene Oxide


[10849296005606]

Ethylene Oxide


[10849296005606]

Ethylene Oxide


[10849296005606]

Ethylene Oxide


[10849296005606]

Ethylene Oxide


[10849296005606]

Ethylene Oxide


[10849296005606]

Ethylene Oxide


[10849296005606]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-08
Device Publish Date2017-06-14

Devices Manufactured by WELMED INC.

00849296000574 - NA2019-10-23
00849296005258 - NA2019-10-23
10849296007396 - NA2019-10-23
00849296000017 - NA2018-11-08
10849296000090 - NA2018-11-08
10849296000106 - NA2018-11-08
10849296000113 - NA2018-11-08
10849296000663 - NA2018-11-08

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