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, Abdominal (FSD) (6) Splint, Extremity, Noninflatable, External, Sterile (FYH) (4)

Premarket Exempt

No Yes

Clear

Dale Bendable Armboard - 00817612020285 Catalog Number : 650

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

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : FYH

Prescription Use : No

Device Count : 1

Dale Bendable Armboard - 00817612020308 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 - 00817612020322 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 - 00817612020346 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 Abdominal Binder - 00817612020360 Catalog Number : 410

Device Description : Dale Abdominal Binder, 9" wide, stretches to fit 30"-45", 1 per box.

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : FSD

Prescription Use : No

Device Count : 1

Dale Abdominal Binder - 00817612020377 Catalog Number : 411

Device Description : Dale Abdominal Binder, 9"wide, stretches to fit 46"-62", 1 per box.

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : FSD

Prescription Use : No

Device Count : 1

Dale Abdominal Binder - 00817612020384 Catalog Number : 418

Device Description : Dale Abdominal Binder, 9" wide, stretches to fit 60"-75", 1 per box.

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : FSD

Prescription Use : No

Device Count : 1

Dale Abdominal Binder - 00817612020391 Catalog Number : 525

Device Description : Dale Abdominal Binder, 6" wide, stretches to fit 28"-50", 1 per box

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : FSD

Prescription Use : No

Device Count : 1

Dale Abdominal Binder - 00817612020407 Catalog Number : 810

Device Description : Dale Abdominal Binder, 12" wide, stretches to fit 30"-45", 1 per box.

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : FSD

Prescription Use : No

Device Count : 1

Dale Abdominal Binder - 00817612020414 Catalog Number : 811

Device Description : Dale Abdominal Binder, 12" wide, stretches to fit 46"-62", 1 per box.

Device Class : 1

Duns Number: 001061233

Premarket Exempt : Yes

Product Code : FSD

Prescription Use : No

Device Count : 1

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