KROGER CO., THE

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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

Needle, Hypodermic, Single Lumen (FMI) (7) Case, Contact Lens (LRX) (1) Lancet, Blood (FMK) (1) Tape And Bandage, Adhesive (KGX) (1)

Premarket Exempt

Yes No

Clear

Kroger Pen Needles - 00041260003592 Catalog Number :

Device Description : Sterile, single-use, 6-bevel pen needles, 31 gauge, 6mm (1/4") length, extra-thin wall

Device Class :

Duns Number: 006999528

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

Kroger Pen Needles - 00041260003608 Catalog Number :

Device Description : Sterile, single-use, 6-bevel pen needles, 31 Gauge, 8mm (5/16") Length, extra-thin wall

Device Class :

Duns Number: 006999528

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

Kroger - 00041260007224 Catalog Number :

Device Description : Kroger Pentips, 5mm x 31G, 100 ct

Device Class :

Duns Number: 006999528

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 100

Kroger - 00041260007231 Catalog Number :

Device Description : Kroger Pentips, 4mm x 33G, 100 ct

Device Class :

Duns Number: 006999528

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 100

Kroger - 00041260007774 Catalog Number :

Device Description : Kroger Pentips, 6mm x 31G, 100 ct

Device Class :

Duns Number: 006999528

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 100

Kroger - 00041260007781 Catalog Number :

Device Description : Kroger Pentips, 4mm x 32G, 100 ct

Device Class :

Duns Number: 006999528

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 100

Kroger - 00041260007798 Catalog Number :

Device Description : Kroger Pentips, 8mm x 31G, 100 ct

Device Class :

Duns Number: 006999528

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 100

Kroger - 00041260007804 Catalog Number :

Device Description : Kroger Autolet Lancing Device

Device Class :

Duns Number: 006999528

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

Kroger - 00041260008726 Catalog Number :

Device Description : Tan Kinesiology Tape, 1 roll with 20 Pre-cut strips, 2 IN x 5.4 YDS (50 mm x 5 m)

Device Class : 1

Duns Number: 006999528

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Kroger - 00041260008788 Catalog Number :

Device Description : KG OPP CONTACT CASE 3CT

Device Class :

Duns Number: 006999528

Premarket Exempt : No

Product Code : LRX

Prescription Use : No

Device Count : 3

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