KEY SURGICAL, INC.

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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

Instrument, Manual, Surgical, General Use (MDM) (9) Clamp, Surgical, General & Plastic Surgery (GDJ) (1)

Premarket Exempt

Yes No

Clear

Key Surgical Suture Booties - 00849771010739 Catalog Number :

Device Description : Suture Booties, Blue, Sterile, 5 pair/pad; 5 pads/box

Device Class : 1

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : GDJ

Prescription Use : No

Device Count : 1

Instrument Stringers - 00849771011378 Catalog Number :

Device Description : Instrument Stringers, stainless steel, 4" x 2.5"

Device Class : 1

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

Instrument Stringers - 00849771011385 Catalog Number :

Device Description : Instrument Stringers, stainless steel, 6" x 2.5"

Device Class : 1

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

Instrument Stringers - 00849771011392 Catalog Number :

Device Description : Instrument Stringers, stainless steel, 8" x 2.5"

Device Class : 1

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

Instrument Stringers - 00849771011408 Catalog Number :

Device Description : Instrument Stringers, stainless steel, 10" x 2.5"

Device Class : 1

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

Instrument Stringers - 00849771011415 Catalog Number :

Device Description : Instrument Stringers, Spring Lock, Surgical Stainless Steel, 6" x 2.75"

Device Class : 1

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

Instrument Stringers - 00849771011422 Catalog Number :

Device Description : Instrument Stringers, Spring Lock, Surgical Stainless Steel, 8" x 2.75"

Device Class : 1

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

Instrument Stringers - 00849771011439 Catalog Number :

Device Description : Instrument Stringers, Spring Lock, Surgical Stainless Steel, 10" x 2.75"

Device Class : 1

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

Instrument Stringers - 00849771011446 Catalog Number :

Device Description : Instrument Stringers, Spring Lock, Surgical Stainless Steel, 12" x 2.75"

Device Class : 1

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

K-Wire & Steinmann Pin Dispensers - 00849771011491 Catalog Number :

Device Description : K-Wire & Steinmann Pin Dispensers, Multi-Chambered, 12", Holds .035

Device Class : 1

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

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