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

BANDAGE, ELASTIC (FQM) (7) Drape, surgical (KKX) (3)

Premarket Exempt

No Yes

Clear

Spectrum, Inc. - 00850301007242 Catalog Number : 781986

Device Description : Sterile Equipment Drape, Gama Probe, 5"X96"

Device Class : 2

Duns Number: 080458964

Premarket Exempt : No

Product Code : KKX

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007273 Catalog Number : 781988

Device Description : Sterile Equipment Drape, Cordless Gama Probe, 1"X12"

Device Class : 2

Duns Number: 080458964

Premarket Exempt : No

Product Code : KKX

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007297 Catalog Number : 956920WOLF

Device Description : Sterile Equipment Drape, ACUSON, 5" X 72"

Device Class : 2

Duns Number: 080458964

Premarket Exempt : No

Product Code : KKX

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007341 Catalog Number : 714309

Device Description : Sterile Pressure Bandage, Esmarch, 3" x 9'

Device Class : 1

Duns Number: 080458964

Premarket Exempt : No

Product Code : FQM

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007365 Catalog Number : 714312

Device Description : Sterile Pressure Bandage, Esmarch, 3" x 12'

Device Class : 1

Duns Number: 080458964

Premarket Exempt : No

Product Code : FQM

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007389 Catalog Number : 714409

Device Description : Sterile Pressure Bandage, Esmarch, 4" x 9'

Device Class : 1

Duns Number: 080458964

Premarket Exempt : No

Product Code : FQM

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007402 Catalog Number : 714412

Device Description : Sterile Pressure Bandage, Esmarch, 4" x 12'

Device Class : 1

Duns Number: 080458964

Premarket Exempt : No

Product Code : FQM

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007419 Catalog Number : 714609

Device Description : Sterile Pressure Bandage, Esmarch, 6" x 9'

Device Class : 1

Duns Number: 080458964

Premarket Exempt : No

Product Code : FQM

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007440 Catalog Number : 714612

Device Description : Sterile Pressure Bandage, Esmarch, 6" x 12'

Device Class : 1

Duns Number: 080458964

Premarket Exempt : No

Product Code : FQM

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007464 Catalog Number : 713309

Device Description : Sterile Pressure Bandage, Esmarch, w/CSR Wrap - 3" x 9'

Device Class : 1

Duns Number: 080458964

Premarket Exempt : No

Product Code : FQM

Prescription Use : Yes

Device Count : 1

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