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

Container, frozen donor tissue storage (LPZ) (7) BANDAGE, CAST (ITG) (2) CUSHION, FLOTATION (KIC) (1)

Premarket Exempt

No Yes

Clear

Spectrum, Inc. - 00850301007761 Catalog Number : 721247

Device Description : Sterile Heel/Elbow Flotation Cushion, Large Size

Device Class :

Duns Number: 080458964

Premarket Exempt : Yes

Product Code : KIC

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007778 Catalog Number : 712804LF

Device Description : Rapid Wrap Bandage, 4" x 5 Yards, Non-Sterile

Device Class : 1

Duns Number: 080458964

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007785 Catalog Number : 712806LF

Device Description : Rapid Wrap Bandage, 6" x 5 Yards, Non-Sterile

Device Class : 1

Duns Number: 080458964

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007792 Catalog Number : 725100

Device Description : Specimin Container, 32 Oz, Sterile

Device Class : U

Duns Number: 080458964

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007808 Catalog Number : 725200

Device Description : Specimine Container, 16 Oz, Sterile

Device Class : U

Duns Number: 080458964

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007815 Catalog Number : 725300

Device Description : LDPE Specimine Containers, 16 & 32 Oz, Sterile

Device Class : U

Duns Number: 080458964

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007822 Catalog Number : 725400

Device Description : LDPE Specimine Containers, 32 & 64 Oz, Sterile

Device Class : U

Duns Number: 080458964

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007839 Catalog Number : 725500

Device Description : Specimine Container, 64 Oz, Sterile

Device Class : U

Duns Number: 080458964

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007846 Catalog Number : 725600

Device Description : Specimine Container, 8 Oz, Non-Sterile

Device Class : U

Duns Number: 080458964

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00850301007853 Catalog Number : 725700

Device Description : Specimine Container, 8 Oz, Sterile

Device Class : U

Duns Number: 080458964

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

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