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) (7) Indicator, Physical/Chemical Sterilization Process (JOJ) (2) Clamp, Surgical, General & Plastic Surgery (GDJ) (1)

Premarket Exempt

No Yes

Clear

Key Surgical K-Wire and Pin Covers - 00849771000723 Catalog Number :

Device Description : Pin Covers, Sterile, Orange, .177-inch, 4.5mm, 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 - 00849771000969 Catalog Number :

Device Description : Pin Covers, Sterile, Navy, .156" / 4.0mm, 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 - 00849771000976 Catalog Number : C141

Device Description : Pin Covers, Sterile, Brown, 0.137-inch, 3.5mm, 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 - 00849771000983 Catalog Number :

Device Description : Pin Covers, Sterile, Lavender, .125" / 3.2mm, 2/pkg

Device Class :

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 2

Key Surgical Indicator Dot Locking Tags - 00849771001959 Catalog Number : LS-100

Device Description : Indicator Dot Locking Tag, Steam Sterilization. 100 Tags

Device Class : 2

Duns Number: 604056226

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

Key Surgical Indicator Dot Locking Tags - 00849771001966 Catalog Number : LS-400

Device Description : Indicator Dot Locking Tag, Red, Steam Sterilization. 100 Tags

Device Class : 2

Duns Number: 604056226

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

Key Surgical Suture Booties - 00849771002666 Catalog Number :

Device Description : Suture Booties, White, 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

Key Surgical K-Wire and Pin Covers - 00849771003632 Catalog Number :

Device Description : Pin Covers, Sterile, Tan, .109" / 2.8mm, 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 - 00849771003649 Catalog Number :

Device Description : Pin Covers, Sterile, Gray, .093" / 2.4mm, 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 - 00849771003717 Catalog Number :

Device Description : Pin Covers, Sterile, Pink, .078" / 2.0mm, 2/pkg

Device Class :

Duns Number: 604056226

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 2

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