Welmed, Inc.

GUDID 00849296004916

Fracture Table Hip Drape, Sterile, 1 per/pack, 18 packs/case

WELMED INC.

Patient surgical drape, single-use
Primary Device ID00849296004916
NIH Device Record Keyd6c725e7-0a30-43fe-a5ea-d7cc623f51a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameWelmed, Inc.
Version Model Number1222-8652
Company DUNS828213426
Company NameWELMED 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 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
GS100849296004916 [Primary]

FDA Product Code

PUIDrape, Surgical, Exempt

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00849296004916]

Ethylene Oxide


[00849296004916]

Ethylene Oxide


[00849296004916]

Ethylene Oxide


[00849296004916]

Ethylene Oxide


[00849296004916]

Ethylene Oxide


[00849296004916]

Ethylene Oxide


[00849296004916]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-30
Device Publish Date2026-03-20

Devices Manufactured by WELMED INC.

00849296004916 - Welmed, Inc.2026-03-30Fracture Table Hip Drape, Sterile, 1 per/pack, 18 packs/case
00849296004916 - Welmed, Inc.2026-03-30 Fracture Table Hip Drape, Sterile, 1 per/pack, 18 packs/case
00849296009898 - Welmed2026-02-23 Cysto-Bladder, Irrigation Set, 81”, Roller Clamp, 40 per case
00849296009911 - Welmed2026-02-23 Y-type TUR, Bladder-Irrigation Set, 81”, 40 per case
00849296013345 - Welmed2026-02-23 Syringe, 1cc, TB, Non-Sterile Bulk, 250 each/ bag, 20/bag, 5000 each/case
00849296013352 - Welmed2026-02-23 Syringe, 2cc, Luer Lock, 3600 each/case
00849296013369 - Welmed2026-02-23 Syringe, 3cc, Luer Lock, Non-Sterile Bulk, 3800 each/case
00849296013376 - Welmed2026-02-23 Syringe, 3cc, Luer Slip, 3800 each/case
00849296013383 - Welmed2026-02-23 Syringe, 5cc, Luer Lock, Non-Sterile Bulk, 900 each/bag, 2 bags/case, 1800 each/case

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