GUDID 00849296000574

WELMED INC.

Surgical gown, single-use
Primary Device ID00849296000574
NIH Device Record Key4bfeed3f-9cbf-441e-bfb7-59ee69e7fd55
Commercial Distribution StatusIn Commercial Distribution
Version Model Number1231-050L
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
GS100849296000574 [Primary]
GS110849296000571 [Package]
Package: [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FYAGown, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00849296000574]

Ethylene Oxide


[00849296000574]

Ethylene Oxide


[00849296000574]

Ethylene Oxide


[00849296000574]

Ethylene Oxide


[00849296000574]

Ethylene Oxide


[00849296000574]

Ethylene Oxide


[00849296000574]

Ethylene Oxide


[00849296000574]

Ethylene Oxide


[00849296000574]

Ethylene Oxide


[00849296000574]

Ethylene Oxide


[00849296000574]

Ethylene Oxide


[00849296000574]

Ethylene Oxide


[00849296000574]

Ethylene Oxide


[00849296000574]

Ethylene Oxide


[00849296000574]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-23
Device Publish Date2016-11-29

Devices Manufactured by WELMED INC.

00849296000574 - NA2019-10-23
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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