Hayden Medical, Inc.

Address:19425 Soledad Cyn Rd,Santa Clarita,CA,91351,US

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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

HANDLE, SCALPEL (GDZ) (9) TAPE, MEASURING, RULERS AND CALIPERS (FTY) (1)

Premarket Exempt

No Yes

Clear

Hayden Medical - 00840319700006 Catalog Number : 040-407

Device Description : Scalpel Handle #3 Graduated CM's - for blade sizes #10-15, extra fine 5" (12.5cm)

Device Class : 1

Duns Number: 618214410

Premarket Exempt : Yes

Product Code : GDZ

Prescription Use : Yes

Device Count : 1

Hayden Medical - 00840319700013 Catalog Number : 040-400

Device Description : Miniature Blade Handle w/ chuck, 3-3/4" (9.5cm), round knurled (3k type)

Device Class : 1

Duns Number: 618214410

Premarket Exempt : Yes

Product Code : GDZ

Prescription Use : Yes

Device Count : 1

Hayden Medical - 00840319700020 Catalog Number : 040-401

Device Description : Miniature Blade Handle w/ self-locking chuck, 3-3/4" (9.5cm), round knurled (3k type)

Device Class : 1

Duns Number: 618214410

Premarket Exempt : Yes

Product Code : GDZ

Prescription Use : Yes

Device Count : 1

Hayden Medical - 00840319700037 Catalog Number : 030-006

Device Description : Ruler Flexible Stainless Steel 6" (15cm) x 1/2" (1.3cm), graduated in 1/32" (.8m Ruler Flexible Stainless Steel 6" (15cm) x 1/2" (1.3cm), graduated in 1/32" (.8mm) fractions & mm's

Device Class : 1

Duns Number: 618214410

Premarket Exempt : Yes

Product Code : FTY

Prescription Use : Yes

Device Count : 1

Hayden Medical - 00840319700044 Catalog Number : 040-407X

Device Description : #3 Scalpel Handle 12" (30cm), for blade sizes #10-15, extra length

Device Class : 1

Duns Number: 618214410

Premarket Exempt : Yes

Product Code : GDZ

Prescription Use : Yes

Device Count : 1

Hayden Medical - 00840319700051 Catalog Number : 040-407XL

Device Description : #3 Scalpel Handle 14" (35cm), for blade sizes #10-15, XL

Device Class : 1

Duns Number: 618214410

Premarket Exempt : Yes

Product Code : GDZ

Prescription Use : Yes

Device Count : 1

Hayden Medical - 00840319700068 Catalog Number : 040-407XXL

Device Description : #3 Scalpel Handle 16" (40cm), for blade sizes #10-15, XXL

Device Class : 1

Duns Number: 618214410

Premarket Exempt : Yes

Product Code : GDZ

Prescription Use : Yes

Device Count : 1

Hayden Medical - 00840319700075 Catalog Number : 040-407XXXL

Device Description : #3 Scalpel Handle 18" (45cm), for blade sizes #10-15, XXXL - CUSTOM-

Device Class : 1

Duns Number: 618214410

Premarket Exempt : Yes

Product Code : GDZ

Prescription Use : Yes

Device Count : 1

Hayden Medical - 00840319700082 Catalog Number : 040-408

Device Description : Scalpel Handle #4 - for blade sizes #20-25, extra fine 5-1/4" (13.1cm)

Device Class : 1

Duns Number: 618214410

Premarket Exempt : Yes

Product Code : GDZ

Prescription Use : Yes

Device Count : 1

Hayden Medical - 00840319700099 Catalog Number : 040-409

Device Description : Scalpel Handle #7 for blade sizes #10-15, extra fine 6-1/4" (15.6cm)

Device Class : 1

Duns Number: 618214410

Premarket Exempt : Yes

Product Code : GDZ

Prescription Use : Yes

Device Count : 1

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