GUDID 10849296005354

WELMED INC.

Patient surgical drape, single-use, sterile
Primary Device ID10849296005354
NIH Device Record Key6e2312c7-4bdf-4a76-8419-1b08cae2b02c
Commercial Distribution StatusIn Commercial Distribution
Version Model Number1224-006
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
GS100849296005357 [Primary]
GS110849296005354 [Package]
Contains: 00849296005357
Package: [80 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KKXDrape, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10849296005354]

Ethylene Oxide


[10849296005354]

Ethylene Oxide


[10849296005354]

Ethylene Oxide


[10849296005354]

Ethylene Oxide


[10849296005354]

Ethylene Oxide


[10849296005354]

Ethylene Oxide


[10849296005354]

Ethylene Oxide


[10849296005354]

Ethylene Oxide


[10849296005354]

Ethylene Oxide


[10849296005354]

Ethylene Oxide


[10849296005354]

Ethylene Oxide


[10849296005354]

Ethylene Oxide


[10849296005354]

Ethylene Oxide


[10849296005354]

Ethylene Oxide


[10849296005354]

Ethylene Oxide


[10849296005354]

Ethylene Oxide


[10849296005354]

Ethylene Oxide


[10849296005354]

Ethylene Oxide


[10849296005354]

Ethylene Oxide


[10849296005354]

Ethylene Oxide


[10849296005354]

Ethylene Oxide


[10849296005354]

Ethylene Oxide


[10849296005354]

Ethylene Oxide


[10849296005354]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.