FDA.reportPublic FDA data

ENDURE INDUSTRIES

Primary DI
00840118620468
Brand
ENDURE INDUSTRIES
Company
ENDURE INDUSTRIES
Model
GSTL
Catalog number
GSTL
Device description
Disposable Exam Shorts Large
Published
2026-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMEGown, Examination

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMEGown, ExaminationGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840118620475PackageGS1100In Commercial Distribution
00840118620468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840118620475008401186204758401186204750840118620475
00840118620468008401186204688401186204680840118620468

GMDN Terms#

Term, Definition table
TermDefinition
Patient gown, single-useA non-sterile garment made of natural and/or synthetic materials (e.g., paper, cloth, plastic) intended to be worn by patients in a clinical setting (e.g., during hospitalization, during examination in a doctor's office). A patient gown is usually short-sleeved and may be closed by ties at the back/side of the garment. This is a single-use garment.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
6072994971support@endureind.com

Regulatory Flags#

DUNS number
066087031
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840118617567Endure IndustriesECLJBSECLJBS-302026-08-03
00840118617581Endure IndustriesECLJBMECLJBM2026-08-03
00840118617604Endure IndustriesECLJBLECLJBL2026-08-03
00840118617628Endure IndustriesECLJBXLECLJBXL2026-08-03
00840118617659ENDURE INDUSTRIESELCKSELCKS2026-08-03
00840118617673Endure IndustriesELCKMELCKM2026-08-03
00840118617697Endure IndustriesELCKLELCKL2026-08-03
00840118617710Endure IndustriesELCKXLELCKXL2026-08-03
00840118617741Endure IndustriesELCKXXLELCKXXL2026-08-03
00840118617772Endure IndustriesELCTSELCTS2026-08-03
00840118617802Endure IndustriesELCTMELCTM2026-08-03
00840118620444ENDURE INDUSTRIESGSTMGSTM2026-08-03
00840118620482ENDURE INDUSTRIESGSTXGSTX2026-08-03
00840118687690Endure IndustriesELCTLELCTL2026-08-03
00840118698399Endure IndustriesELCTXLELCTXL2026-08-03
00840118608046ENDURE INDUSTRIESNROMA11NROMA112024-04-01
00840118608060ENDURE INDUSTRIESNROMP11NROMP112024-04-10
00840118611619ENDURE INDUSTRIESNROMPE11NROMPE112024-04-10
00840118611633ENDURE INDUSTRIESNROMAE11NROMAE112024-04-01
00840118612791ENDURE INDUSTRIESA2001A20012023-10-15

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Primary DI, Brand, Company table
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10850053289566SURGYCOSurgyco LLCFME2024-08-09
10850053289573SURGYCOSurgyco LLCFME2024-08-09
10850053289740SURGYCOSurgyco LLCFME2024-08-09
10850053289757SURGYCOSurgyco LLCFME2024-08-09
10810141931388VIVIT SupplyVivit Supply LLCFME2024-01-19
10810141931395VIVIT SupplyVivit Supply LLCFME2024-01-19
10850045738065UNCThe University of North Carolina Health SystemFME2023-10-31