Greenguard

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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

Tape And Bandage, Adhesive (KGX) (4) Gauze / Sponge,Nonresorbable For External Use (NAB) (2) Pack, Hot Or Cold, Disposable (IMD) (2) Dressing, Wound, Hydrophilic (NAC) (1) Refrigerant, Topical (Vapocoolant) (MLY) (1)

Premarket Exempt

No Yes

Clear

Green Guard Cold Spray - 00347682030056 Catalog Number : 3005

Device Description : A non-sterile liquid in a spray container intended for localized application to A non-sterile liquid in a spray container intended for localized application to the body surface to provide a cooling effect for underlying muscles/joints to reduce pain and swelling.

Device Class : U

Duns Number: 176528040

Premarket Exempt : No

Product Code : MLY

Prescription Use : No

Device Count : 1

Green Guard Instant Cold Pack - 00347682033002 Catalog Number : 3300

Device Description : A device intended to be applied with pressure to the body surface to provide col A device intended to be applied with pressure to the body surface to provide cold therapy - large

Device Class : 1

Duns Number: 176528040

Premarket Exempt : Yes

Product Code : IMD

Prescription Use : No

Device Count : 1

Green GuardInstant Cold Pack - 00347682033026 Catalog Number : 3302

Device Description : A device intended to be applied with pressure to the body surface to provide col A device intended to be applied with pressure to the body surface to provide cold therapy - Medium

Device Class : 1

Duns Number: 176528040

Premarket Exempt : Yes

Product Code : IMD

Prescription Use : No

Device Count : 1

Green Guard Sterile Gauze Pads - 00347682062019 Catalog Number : 6201

Device Description : 2 x 2 pad,10 count box of a non-medicated sterile device in the form of a patch 2 x 2 pad,10 count box of a non-medicated sterile device in the form of a patch made from woven material (e.g., cotton).

Device Class : 1

Duns Number: 176528040

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 1

Green Guard Sterile Gauze Pads - 00347682062057 Catalog Number : 6205

Device Description : 3 x 3 10count box of a non-medicated sterile device in the form of a patch made 3 x 3 10count box of a non-medicated sterile device in the form of a patch made from woven material (e.g., cotton)

Device Class :

Duns Number: 176528040

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 1

Green Guard Non-Adherent Pads - 00347682062156 Catalog Number : 6215

Device Description : A non-medicated sterile device in the form of a patch made from non-woven materi A non-medicated sterile device in the form of a patch made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes.

Device Class : 1

Duns Number: 176528040

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

Green Guard Fabric Strip Bandages - 00347682063009 Catalog Number : 6300

Device Description : A small, narrow, flexible band of fabric material coated on one side with a pres A small, narrow, flexible band of fabric material coated on one side with a pressure-sensitive adhesive and an absorbent pad.

Device Class : 1

Duns Number: 176528040

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Green Guard Fingertip Bandages - 00347682063023 Catalog Number : 6302

Device Description : A small, narrow, flexible band of fabric material for the fingertip coated on on A small, narrow, flexible band of fabric material for the fingertip coated on one side with a pressure-sensitive adhesive and with an absorbent pad.

Device Class : 1

Duns Number: 176528040

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Green Guard Knuckle Bandages - 00347682063047 Catalog Number : 6304

Device Description : A small, narrow, flexible band of fabric material for the knuckle coated on one A small, narrow, flexible band of fabric material for the knuckle coated on one side with a pressure-sensitive adhesive and with an absorbent pad.

Device Class : 1

Duns Number: 176528040

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Green Guard Large Patch Bandage - 00347682063061 Catalog Number : 6306

Device Description : A flexible band of fabric material coated on one side with a pressure-sensitive A flexible band of fabric material coated on one side with a pressure-sensitive adhesive and with an absorbent pad.

Device Class : 1

Duns Number: 176528040

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

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