Global Health Solutions LLC

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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

Tampon, Menstrual, Unscented (HEB) (4) Pad, Menstrual, Unscented (HHD) (3) Disinfectant, Medical Devices (LRJ) (1)

Premarket Exempt

No Yes

Clear

2XChromosome - 00850022610004 Catalog Number : WBOZY008

Device Description : Personal Care Cleansing Wipes; individually wrapped, organic cotton, alcohol free

Device Class :

Duns Number: 117588619

Premarket Exempt : Yes

Product Code : LRJ

Prescription Use : No

Device Count : 10

2XChromosome - 00850022610011 Catalog Number : LBOUN001

Device Description : Ultra Thin Panty Liner; individually wrapped, organic cotton top sheet

Device Class :

Duns Number: 117588619

Premarket Exempt : Yes

Product Code : HHD

Prescription Use : No

Device Count : 20

2XChromosome - 00850022610028 Catalog Number : PBORN002

Device Description : Regular Maxi Pad With Wings; individually wrapped, organic cotton top sheet

Device Class :

Duns Number: 117588619

Premarket Exempt : Yes

Product Code : HHD

Prescription Use : No

Device Count : 10

2XChromosome - 00850022610035 Catalog Number : PBOSN003

Device Description : Super Maxi Pad With Wings; individually wrapped, organic cotton top sheet

Device Class :

Duns Number: 117588619

Premarket Exempt : Yes

Product Code : HHD

Prescription Use : No

Device Count : 10

2XChromosome - 00850022610042 Catalog Number : TCCLN004

Device Description : Cardboard Applicator Tampons Light; individually wrapped, organic cotton absorbent core

Device Class :

Duns Number: 117588619

Premarket Exempt : No

Product Code : HEB

Prescription Use : No

Device Count : 18

2XChromosome - 00850022610059 Catalog Number : TCCRN005

Device Description : Cardboard Applicator Tampons Regular; individually wrapped, organic cotton absorbent core

Device Class :

Duns Number: 117588619

Premarket Exempt : No

Product Code : HEB

Prescription Use : No

Device Count : 16

2XChromosome - 00850022610066 Catalog Number : TCCSN006

Device Description : Cardboard Applicator Tampons Super; individually wrapped, organic cotton absorbent core

Device Class :

Duns Number: 117588619

Premarket Exempt : No

Product Code : HEB

Prescription Use : No

Device Count : 14

2XChromosome - 00850022610073 Catalog Number : TCCPN007

Device Description : Cardboard Applicator Tampons Super Plus; individually wrapped, organic cotton ab Cardboard Applicator Tampons Super Plus; individually wrapped, organic cotton absorbent core

Device Class :

Duns Number: 117588619

Premarket Exempt : No

Product Code : HEB

Prescription Use : No

Device Count : 14

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