SPECTRUM, 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

Drape, surgical (KKX) (10)

Premarket Exempt

No Yes

Clear

Spectrum, Inc. - 00850301007006 Catalog Number : 706920

Device Description : Sterile Equipment Drape, Universal Camera, 7"X96"

Device Class :

Duns Number: 080458964

Premarket Exempt : No

Product Code : KKX

Prescription Use : Yes

Device Count : 1

Wolf - 00850301007020 Catalog Number : 956920WOL

Device Description : Sterile Equipment Drape, ENDOCAM Camera, 7"X96^"

Device Class :

Duns Number: 080458964

Premarket Exempt : No

Product Code : KKX

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007037 Catalog Number : 706931

Device Description : Sterile Equipment Drape, Tear Tip, 7"X96"

Device Class :

Duns Number: 080458964

Premarket Exempt : No

Product Code : KKX

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007068 Catalog Number : 706921

Device Description : Sterile Equipment Drape, Universal Camera, 5"X96"

Device Class : 2

Duns Number: 080458964

Premarket Exempt : No

Product Code : KKX

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007099 Catalog Number : 706925

Device Description : Sterile Equipment Drape, C Arm, 27"X17"X70"

Device Class :

Duns Number: 080458964

Premarket Exempt : No

Product Code : KKX

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007112 Catalog Number : 704912

Device Description : Sterile Equipment Drape, TV Camera, 8"X120" w/straps

Device Class : 2

Duns Number: 080458964

Premarket Exempt : No

Product Code : KKX

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007150 Catalog Number : 706932

Device Description : Sterile Equipment Drape, Tear Tip, 5"X96"

Device Class :

Duns Number: 080458964

Premarket Exempt : No

Product Code : KKX

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007181 Catalog Number : 706952

Device Description : Sterile Equipment Drape, Robotic Stow Arm, 18"X78"

Device Class : 2

Duns Number: 080458964

Premarket Exempt : No

Product Code : KKX

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007204 Catalog Number : 781983

Device Description : Sterile Equipment Drape, Ultrasound probe, 8" X 55"

Device Class : 2

Duns Number: 080458964

Premarket Exempt : No

Product Code : KKX

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007228 Catalog Number : 781984

Device Description : Sterile Equipment Drape, Ultrasonic Probe, 7"X96"

Device Class : 2

Duns Number: 080458964

Premarket Exempt : No

Product Code : KKX

Prescription Use : Yes

Device Count : 1

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