GUDID 20849296003463

WELMED INC.

Patient surgical drape, single-use, sterile
Primary Device ID20849296003463
NIH Device Record Key218abfd7-aa59-4d90-89d5-e1de2c1f294c
Commercial Distribution StatusIn Commercial Distribution
Version Model Number1501-2050
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
GS100849296003469 [Primary]
GS110849296003466 [Package]
Contains: 00849296003469
Package: [10 Units]
In Commercial Distribution
GS120849296003463 [Package]
Contains: 10849296003466
Package: [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KKXDrape, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20849296003463]

Ethylene Oxide


[20849296003463]

Ethylene Oxide


[20849296003463]

Ethylene Oxide


[20849296003463]

Ethylene Oxide


[20849296003463]

Ethylene Oxide


[20849296003463]

Ethylene Oxide


[20849296003463]

Ethylene Oxide


[20849296003463]

Ethylene Oxide


[20849296003463]

Ethylene Oxide


[20849296003463]

Ethylene Oxide


[20849296003463]

Ethylene Oxide


[20849296003463]

Ethylene Oxide


[20849296003463]

Ethylene Oxide


[20849296003463]

Ethylene Oxide


[20849296003463]

Ethylene Oxide


[20849296003463]

Ethylene Oxide


[20849296003463]

Ethylene Oxide


[20849296003463]

Ethylene Oxide


[20849296003463]

Ethylene Oxide


[20849296003463]

Ethylene Oxide


[20849296003463]

Ethylene Oxide


[20849296003463]

Ethylene Oxide


[20849296003463]

Ethylene Oxide


[20849296003463]

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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