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) (3) CUSHION, FLOTATION (KIC) (1)

Premarket Exempt

No Yes

Clear

Spectrum, Inc. - 00855495007368 Catalog Number : GCS-6920

Device Description : Sterile Equipment Drape, AssistArm Surgical Drape, 7" X 96", Latex Free

Device Class :

Duns Number: 080458964

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00855495007375 Catalog Number : Murray 016538

Device Description : Non-sterile Equipment Drape, Disposable Sheath, Bulk

Device Class : U

Duns Number: 080458964

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00855495007382 Catalog Number : 956923LUM

Device Description : Sterile Equipment Drape, Microlase, 5" X 59", latex Free

Device Class :

Duns Number: 080458964

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

Spectrum, Inc. - 00855495007405 Catalog Number : 75658-00003-00

Device Description : Non-Sterile Heel/Elbow Protection Cushion

Device Class :

Duns Number: 080458964

Premarket Exempt : Yes

Product Code : KIC

Prescription Use : No

Device Count : 1

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