FDA.reportPublic FDA data

MoonPants SM

Primary DI
00893029002595
Brand
MoonPants SM
Company
GI Supply, Inc.
Model
GIS-7-SM
Catalog number
GIS-7-SM
Device description
MoonPants SM single-use non-sterile garment
Published
2021-07-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10893029002592PackageGS150In Commercial Distribution
00893029002595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089302900259210893029002592
00893029002595008930290025958930290025950893029002595

GMDN Terms#

Term, Definition table
TermDefinition
Surgical patient underpantsA pair of underpants/shorts made of natural and/or synthetic materials (e.g., paper, cloth, plastic) intended to be worn by a patient for comfort, covering, and a degree of warmth before, during, and/or after a surgical intervention; it may have an opening(s)/access port(s) to allow access to body orifices. It is not specifically intended for support, and is typically loose fitting or elasticated to accommodate a variety of sizes; it does not include antimicrobial properties. This is a single-use garment.

Contacts#

Phone, Email table
PhoneEmail
800-451-5797info@gi-supply.com

Regulatory Flags#

DUNS number
160990313
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00893029002762JADA System10471962026-07-17
00893029002786JADA System5000512026-07-17
00893029002809JADA System5000622026-07-17
00893029002823JADA System5000522026-07-17
00893029002830JADA System8000126/5000612026-07-17
00893029002854JADA System5000632026-07-17
00893029002878JADA System10501372026-07-17
00893029002892JADA System10503452026-07-17
00893029002601MoonPants MLGIS-7-MLGIS-7ML2021-07-20
00893029002618MoonPants XLGIS-7-XLGIS-7-XL2021-07-20
00893029002625MoonPants LongGIS-13GIS-132021-07-20
00893029002632SportShorts XSSL-9XSSL-9XS2021-07-20
00893029002649SportShorts SMSL-9SMSL-9SM2021-07-20
00893029002656SportShorts MLSL-9MLSL-9ML2021-07-20
00893029002663SportShorts XLSL-9XLSL-9XL2021-07-20
00893029002243EverLiftGIS-59GIS-592021-02-18
00893029002229EverLiftGIS-55GIS-552021-02-18
00893029002236RenovaRPGIS-31GIS-312021-07-08
00893029002175RenovaRPGIS-32GIS-322021-07-06
00893029002731RenovaRPGIS-35GIS-352023-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842942015441PRIMEDpriMED Medical Products IncFME2026-02-10
16975803530881GSOGroup Supply Organization Medical Technology(Shanghai) LtdFME2025-11-30
00842942017520PRIMED / CaracalpriMED Medical Products IncFME2025-11-26
00842942017537PRIMED / CaracalpriMED Medical Products IncFME2025-11-26
00842942007828PRIMEDpriMED Medical Products IncFME2025-07-21
00842942008207PRIMEDpriMED Medical Products IncFME2025-07-21
00842942009341PRIMEDpriMED Medical Products IncFME2025-07-21
00842942009358PRIMEDpriMED Medical Products IncFME2025-07-21
00842942009365PRIMEDpriMED Medical Products IncFME2025-07-21
00842942009372PRIMEDpriMED Medical Products IncFME2025-07-21
00842942009556PRIMEDpriMED Medical Products IncFME2025-07-21
00842942009563PRIMEDpriMED Medical Products IncFME2025-07-21
00842942013928PRIMEDpriMED Medical Products IncFME2025-07-21
00842942014475PRIMEDpriMED Medical Products IncFME2025-07-21
00842942014482PRIMEDpriMED Medical Products IncFME2025-07-21
00842942016080PRIMEDpriMED Medical Products IncFME2025-07-21
05391534524410PRIMEDpriMED Medical Products IncFME2025-07-21
05391534524441PRIMEDpriMED Medical Products IncFME2025-07-15
10097604573327Tronex International, Inc.TRONEX INTERNATIONAL, INC.FME2024-12-30
10850053289511SURGYCOSurgyco LLCFME2024-08-09
10850053289559SURGYCOSurgyco LLCFME2024-08-09
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
10810141930473VIVIT SupplyVivit Supply LLCFME2023-09-15
10810141930480VIVIT SupplyVivit Supply LLCFME2023-09-15