GI Supply, Inc.

Address:5069 Ritter Road,Mechanicsburg,PA,17055,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Gown, Examination (FME) (7)

Premarket Exempt

No Yes

Clear

MoonPants ML - 00893029002601 Catalog Number : GIS-7ML

Device Description : MoonPants ML single-use non-sterile garment

Device Class : 1

Duns Number: 160990313

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

MoonPants XL - 00893029002618 Catalog Number : GIS-7-XL

Device Description : MoonPants XL single-use non-sterile garment

Device Class : 1

Duns Number: 160990313

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

MoonPants Long - 00893029002625 Catalog Number : GIS-13

Device Description : MoonPants Long single-use non-sterile garment

Device Class : 1

Duns Number: 160990313

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

SportShorts XS - 00893029002632 Catalog Number : SL-9XS

Device Description : SportShorts XS single-use non-sterile garment

Device Class : 1

Duns Number: 160990313

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

SportShorts SM - 00893029002649 Catalog Number : SL-9SM

Device Description : SportShorts SM single-use non-sterile garment

Device Class : 1

Duns Number: 160990313

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

SportShorts ML - 00893029002656 Catalog Number : SL-9ML

Device Description : SportShorts ML single-use non-sterile garment

Device Class : 1

Duns Number: 160990313

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

SportShorts XL - 00893029002663 Catalog Number : SL-9XL

Device Description : SportShorts XL single-use non-sterile garment

Device Class : 1

Duns Number: 160990313

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

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