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) (8) Instrument, Manual, Surgical, General Use (MDM) (2)

Premarket Exempt

Yes No

Clear

Key Surgical K-Wire and Pin Covers - 00849771008231 Catalog Number :

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

Device Class : 1

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 50

Key Surgical K-Wire and Pin Covers - 00849771008248 Catalog Number :

Device Description : Pin Covers, Non-Sterile, Pink, .078" / 2.0mm, Bulk

Device Class : 1

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 50

Key Surgical K-Wire and Pin Covers - 00849771008255 Catalog Number :

Device Description : Pin Covers, Non-Sterile, Gray, .093" / 2.4mm, Bulk

Device Class : 1

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 50

Key Surgical K-Wire and Pin Covers - 00849771008262 Catalog Number :

Device Description : Pin Covers, Non-Sterile, Tan, .109" / 2.8mm, Bulk

Device Class : 1

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 50

Key Surgical K-Wire and Pin Covers - 00849771008279 Catalog Number :

Device Description : Pin Covers, Non-Sterile, Lavender, .125" / 3.2mm, Bulk

Device Class : 1

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 50

Key Surgical K-Wire and Pin Covers - 00849771008286 Catalog Number :

Device Description : Pin Covers, Non-Sterile, Navy, .156" / 4.0mm, Bulk

Device Class : 1

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 50

Key Surgical K-Wire and Pin Covers - 00849771008293 Catalog Number : C141NS

Device Description : Pin Covers, Non-Sterile, Brown, 0.137-inch, 3.5mm, Bulk

Device Class : 1

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 50

Key Surgical K-Wire and Pin Covers - 00849771008309 Catalog Number :

Device Description : Pin Covers, Non-Sterile , Orange, 0.177-inch, 4.5mm, Bulk

Device Class : 1

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 50

K-Wire & Steinmann Pin Dispensers - 00849771008316 Catalog Number :

Device Description : K-Wire & Steinmann Pin Dispensers, Multi-Chambered, 4", Holds .035/.045/.054/.062 k-wires

Device Class : 1

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

K-Wire & Steinmann Pin Dispensers - 00849771008323 Catalog Number :

Device Description : Raw, K-Wire & Steinmann Pin Dispensers, Multi-Chambered, 12", Holds .035/.045/.0 Raw, K-Wire & Steinmann Pin Dispensers, Multi-Chambered, 12", Holds .035/.045/.054/.062 k-wires

Device Class : 1

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

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