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

Orthopedic Manual Surgical Instrument (LXH) (5) Tray, Surgical (LRP) (5)

Premarket Exempt

No Yes

Clear

Key Surgical K-Wire and Pin Covers - 00849771004059 Catalog Number :

Device Description : K-Wire Covers, Sterile, Green, .062" / 1.6mm, 2/pkg

Device Class :

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 2

Key Surgical K-Wire and Pin Covers - 00849771004097 Catalog Number :

Device Description : K-Wire Covers, Sterile, Red, .054" / 1.4mm, 2/pkg

Device Class :

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 2

Key Surgical K-Wire and Pin Covers - 00849771004165 Catalog Number : C045

Device Description : K-Wire Covers, Sterile, White, .043-inch, 1.1mm, 2 per package

Device Class :

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 2

Key Surgical K-Wire and Pin Covers - 00849771004196 Catalog Number :

Device Description : K-Wire Covers, Sterile, Blue, .035" / 0.9mm, 2/pkg

Device Class :

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 2

Key Surgical K-Wire and Pin Covers - 00849771004226 Catalog Number :

Device Description : K-Wire Covers, Sterile, Yellow, .028" / 0.7mm, 2/pkg

Device Class : 1

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

Key Surgical Trays - 00849771005254 Catalog Number :

Device Description : Instrument Trays & Covers, Micro Tray w/Lid, 40 x 40 x 20mm

Device Class : 1

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : No

Device Count : 1

Key Surgical Trays - 00849771005261 Catalog Number :

Device Description : Instrument Trays & Covers, Micro Tray w/Lid, 80 x 40 x 20mm

Device Class : 1

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : No

Device Count : 1

Key Surgical Trays - 00849771005278 Catalog Number :

Device Description : Instrument Trays & Covers, Micro Tray w/Lid, 160 x 40 x 20mm

Device Class : 1

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : No

Device Count : 1

Key Surgical Trays - 00849771005285 Catalog Number :

Device Description : Instrument Trays & Covers, Micro Tray w/Lid, 70 x 70 x 30mm

Device Class : 1

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : No

Device Count : 1

Key Surgical Trays - 00849771005292 Catalog Number :

Device Description : Instrument Trays & Covers, Micro Tray w/Lid, 80 x 80 x 40mm

Device Class : 1

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : No

Device Count : 1

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