FDA.reportPublic FDA data

Welmed, Inc.

Primary DI
00849296004916
Brand
Welmed, Inc.
Company
WELMED INC.
Model
1222-8652
Device description
Fracture Table Hip Drape, Sterile, 1 per/pack, 18 packs/case
Published
2026-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PUIDrape, Surgical, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849296004916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849296004916008492960049168492960049160849296004916

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-useA noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
828213426
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849296017107Welmed, Inc.IOT-CDS122026-03-26
00849296002790Welmed, Inc.1222-86662017-06-14
00849296003353Welmed, Inc.1501-10182017-06-14
00849296013345Welmed1300-01TB2026-02-15
00849296013352Welmed1300-02LL2026-02-15
00849296013369Welmed1300-03LL2026-02-15
00849296013376Welmed1300-03LS2026-02-15
00849296013383Welmed1300-05LL2026-02-15
00849296013390Welmed1300-05LS2026-02-15
00849296013406Welmed1300-06LL2026-02-15
00849296013413Welmed1300-10CNTL2026-02-15
00849296013420Welmed1300-10LL-8002026-02-15
00849296013437Welmed1300-10LS2026-02-15
00849296013444Welmed1300-12LL2026-02-15
00849296013451Welmed1300-20LL2026-02-15
00849296013475Welmed1300-30LL2026-02-15
00849296013482Welmed1300-30LS2026-02-15
00849296013499Welmed1300-60LL2026-02-15
00849296013505Welmed1300-60LS2026-02-15
00849296009898Welmed1923-4040LFST2026-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918100876AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918102450AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104201AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104416AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104645AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104843AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104935AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918105239AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918106977AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918107400AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918107929AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918108261AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918109640AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918109855AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918109879AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918117102AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918139449AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918179179AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
30680651424465HalyardO&M HALYARD, INC.PUI2026-06-02
50192253071595CONVERTORSCardinal Health 200, LLCPUI2026-06-02
50192253071601CONVERTORSCardinal Health 200, LLCPUI2026-06-02
50192253071618CONVERTORSCardinal Health 200, LLCPUI2026-06-02
50192253071625CONVERTORSCardinal Health 200, LLCPUI2026-06-02
00748426121861OLYMPUSMicrotek Medical LLCPUI2026-05-28
07466532979338Moon SurgicalDAS Medical International SRLPUI2026-05-28
08681756013401PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIPUI2025-12-26
08682952400545PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIPUI2025-12-26
10080196073306MEDLINEMEDLINE INDUSTRIES, INC.PUI2025-06-19
10080196073351MedlineMEDLINE INDUSTRIES, INC.PUI2023-10-24
10080196739240MedlineMEDLINE INDUSTRIES, INC.PUI2023-10-12