DYNAREX CORPORATION

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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

Punch, Surgical (LRY) (3) Cushion, Wheelchair (IMP) (2) Mask, Gas, Anesthetic (BSJ) (2) Tubing, Noninvasive (GAZ) (2) Dressing, Wound, Drug (FRO) (1)

Premarket Exempt

No Yes

Clear

Resp-O2 Air Cushion Mask with Valve, Size #4, Med Adult, (Red Hook) - 00840117321717 Catalog Number :

Device Description : Intended for use in anesthetic therapy

Device Class :

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : BSJ

Prescription Use : No

Device Count : 1

Resp-O2 Air Cushion Mask with Valve, Size #5, Large Adult (Blue Hook) - 00840117321724 Catalog Number :

Device Description : Intended for use in anesthetic therapy

Device Class :

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : BSJ

Prescription Use : No

Device Count : 1

Resp-O2 Suction Connecting Tubing - 00840117321748 Catalog Number :

Device Description : Resp-O2 Suction Connecting Tubing, Non-Conductive, 3/16" x 6' Tube with Male Connector

Device Class :

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : No

Device Count : 1

Resp-O2 Suction Tubing Combo Pack - 00840117321786 Catalog Number :

Device Description : Resp-O2 Suction Tubing Combo Pack, 3/16" x 6' and 3/16" x 18" Tubes with Male Connector

Device Class :

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : No

Device Count : 1

Ever-Soft Lumbar Cushions - 00840117321892 Catalog Number :

Device Description : Ever-Soft Lumbar Cushions, 16"

Device Class :

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : IMP

Prescription Use : No

Device Count : 1

Ever-Soft Air Cell Cushion - 00840117322615 Catalog Number :

Device Description : Ever-Soft Air Cell Cushion, 17.7" x 16.9" x 3.9", Weight Capacity 300 lbs.

Device Class :

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : IMP

Prescription Use : No

Device Count : 1

DynaGinate AG Silver Calcium Alginate Dressing - 00840117322622 Catalog Number :

Device Description : DynaGinate AG Silver Calcium Alginate Dressing, Sterile, 2" x 2" (5cm x 5cm), Hi DynaGinate AG Silver Calcium Alginate Dressing, Sterile, 2" x 2" (5cm x 5cm), High Absorbency, For Wound Stages 3,4

Device Class :

Duns Number: 008124539

Premarket Exempt : No

Product Code : FRO

Prescription Use : No

Device Count : 1

Biopsy Punch, Sterile, 1.5 mm ,White - 00840117322707 Catalog Number :

Device Class :

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : LRY

Prescription Use : No

Device Count : 25

Biopsy Punch, Sterile, 2.0 mm, Ivory - 00840117322714 Catalog Number :

Device Class :

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : LRY

Prescription Use : No

Device Count : 25

Biopsy Punch, Sterile, 2.5 mm, Green - 00840117322721 Catalog Number :

Device Class :

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : LRY

Prescription Use : No

Device Count : 25

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