DALE MEDICAL PRODUCTS, INC.

Address:40 Kenwood Circle,Franklin,MA,02038,US

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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

Binder, Breast (HEF) (4) Splint, Extremity, Noninflatable, External, Sterile (FYH) (4) Tape And Bandage, Adhesive (KGX) (2)

Premarket Exempt

No Yes

Clear

Dale Transducer Holder - H84106201 Catalog Number : 620

Device Description : Dale Transducer Holder, Fits most

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Dale Bendable Armboard - H84106501 Catalog Number : 650

Device Description : Dale Bendable Armboard, Large, 9" x 3.5"

Device Class :

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : FYH

Prescription Use : No

Device Count : 1

Dale Bendable Armboard - H84106511 Catalog Number : 651

Device Description : Dale Bendable Armboard, Medium, 5.38" x 2.5"

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : FYH

Prescription Use : No

Device Count : 1

Dale Bendable Armboard - H84106521 Catalog Number : 652

Device Description : Dale Bendable Armboard, Small, 4.5" x 1.75"

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : FYH

Prescription Use : No

Device Count : 1

Dale Bendable Armboard - H84106531 Catalog Number : 653

Device Description : Dale Bendable Armboard, X-Small, 4.25" x 1"

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : FYH

Prescription Use : No

Device Count : 1

Dale IV Armor - H84106751 Catalog Number : 675

Device Description : Dale IV Armor, Flexible protective overlay, Fits most.

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Dale Post Surgical Bra - H84107021 Catalog Number : 702

Device Description : Dale Post Surgical Bra, Medium, fits B-D, 34"-36", 1 per box.

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : HEF

Prescription Use : No

Device Count : 1

Dale Post Surgical Bra - H84107031 Catalog Number : 703

Device Description : Dale Post Surgical Bra, Large, fits B-D, 36"-38", 1 per box.

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : HEF

Prescription Use : No

Device Count : 1

Dale Post Surgical Bra - H84107041 Catalog Number : 704

Device Description : Dale Post Surgical Bra, X-Large, fits B-D, 38"-44", 1 per box.

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : HEF

Prescription Use : No

Device Count : 1

Dale Post Surgical Bra - H84107051 Catalog Number : 705

Device Description : Dale Post Surgical Bra, XX-Large, fits C-E, 46"-54", 1 per box.

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : HEF

Prescription Use : No

Device Count : 1

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