H. E. BUTT GROCERY COMPANY

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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

Kit, Test, Pregnancy, Hcg, Over The Counter (LCX) (4) Tampon, Menstrual, Unscented (HEB) (3) Radioimmunoassay, Luteinizing Hormone (CEP) (2) Dilator, Nasal (LWF) (1) Floss, Dental (JES) (1)

Premarket Exempt

No Yes

Clear

H-E-B - 00041220410224 Catalog Number : 803933

Device Class :

Duns Number: 007924756

Premarket Exempt : No

Product Code : HEB

Prescription Use : No

Device Count : 24

H-E-B - 00041220410262 Catalog Number : 817895

Device Class :

Duns Number: 007924756

Premarket Exempt : No

Product Code : HEB

Prescription Use : No

Device Count : 24

H-E-B - 00041220410279 Catalog Number : 679686

Device Description : The device will be offered as a traditional unscented menstrual 100% cotton tamp The device will be offered as a traditional unscented menstrual 100% cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The box contains two types of tampons (12+12) offered in two absorbencies: Regular and Super.Each tampon is registered in GUDID database with a different Primary DI Number:- 100% Cotton Tampons Regular: 00041220410224- 100% Cotton Tampons Super: 00041220410262

Device Class : 2

Duns Number: 007924756

Premarket Exempt : No

Product Code : HEB

Prescription Use : No

Device Count : 1

H-E-B - 00041220477692 Catalog Number :

Device Description : Extra Strength Nasal Strips, Clear

Device Class :

Duns Number: 007924756

Premarket Exempt : Yes

Product Code : LWF

Prescription Use : No

Device Count : 26

Rexall - 00041220501120 Catalog Number :

Device Description : Flosser, Center Pick, Hi-Tech, Mint

Device Class : 1

Duns Number: 007924756

Premarket Exempt : Yes

Product Code : JES

Prescription Use : No

Device Count : 150

H.E.B - 00041220524426 Catalog Number :

Device Description : H.E.B One Step Ovulation Predictor

Device Class :

Duns Number: 007924756

Premarket Exempt : No

Product Code : CEP

Prescription Use : No

Device Count : 7

H.E.B - 00041220524433 Catalog Number :

Device Description : FPPL HEB DPS +/-

Device Class :

Duns Number: 007924756

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

H.E.B - 00041220524440 Catalog Number :

Device Description : CB8 HEB DPS Digital Early 2ct

Device Class :

Duns Number: 007924756

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

H.E.B - 00041220524549 Catalog Number :

Device Description : A convenience kit consisting of 10 Ovulation Test devices and 1 One-Step Pregnancy Test.

Device Class : 1

Duns Number: 007924756

Premarket Exempt : No

Product Code : CEP, LCX

Prescription Use : No

Device Count : 1

H.E.B - 00041220524556 Catalog Number :

Device Description : A convenience kit consisting of 1 Digital Pregnancy Test and 1 Early Result Preg A convenience kit consisting of 1 Digital Pregnancy Test and 1 Early Result Pregnancy Test

Device Class : 2

Duns Number: 007924756

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

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