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) (5) Cover, barrier, protective (MMP) (2) Filter, infusion line (FPB) (2) Drape, surgical (KKX) (1)

Premarket Exempt

No Yes

Clear

Spectrum, Inc. - 00850301007471 Catalog Number : 713312

Device Description : Sterile Pressure Bandage, Esmarch, w/CSR Wrap - 3" x 12'

Device Class : 1

Duns Number: 080458964

Premarket Exempt : No

Product Code : FQM

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007488 Catalog Number : 713409

Device Description : Sterile Pressure Bandage, Esmarch, w/CSR Wrap - 4" x 9'

Device Class : 1

Duns Number: 080458964

Premarket Exempt : No

Product Code : FQM

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007495 Catalog Number : 713412

Device Description : Sterile Pressure Bandage, Esmarch, w/CSR Wrap - 4" x 12'

Device Class : 1

Duns Number: 080458964

Premarket Exempt : No

Product Code : FQM

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007501 Catalog Number : 713609

Device Description : Sterile Pressure Bandage, Esmarch, w/CSR Wrap - 6" x 9'

Device Class : 1

Duns Number: 080458964

Premarket Exempt : No

Product Code : FQM

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007518 Catalog Number : 713612

Device Description : Sterile Pressure Bandage, Esmarch, w/CSR Wrap - 6" x 12'

Device Class : 1

Duns Number: 080458964

Premarket Exempt : No

Product Code : FQM

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007587 Catalog Number : DG2M-110-50S

Device Description : Hydrophilic Syringe Tip Filter - DG2M-110-50S, Sterile

Device Class : 2

Duns Number: 039727656

Premarket Exempt : No

Product Code : FPB

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007600 Catalog Number : DG2M-330-100

Device Description : Hydrophilic Syringe Tip Filter - DG2M-330-100, Non- Sterile

Device Class : 2

Duns Number: 039727656

Premarket Exempt : No

Product Code : FPB

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007624 Catalog Number : 781988M

Device Description : Sterile Equipment Drape, Cordless Gama Probe, 1"X11.5"

Device Class : 2

Duns Number: 080458964

Premarket Exempt : No

Product Code : KKX

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007648 Catalog Number : 701424NS

Device Description : Equipment Drape, FT Switch Cover, 14" X 24", Non-sterile

Device Class : 2

Duns Number: 080458964

Premarket Exempt : No

Product Code : MMP

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007655 Catalog Number : 706920NS

Device Description : Equipment Drape, UniversaL Camera, 7" X 96", non-sterile

Device Class : 2

Duns Number: 080458964

Premarket Exempt : No

Product Code : MMP

Prescription Use : Yes

Device Count : 1

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