ASPEN SURGICAL PRODUCTS, INC.

Address:6945 SOUTHBELT DR. S.E.,Caledonia,MI,49316,US

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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

Strip, adhesive, closure, skin (FPX) (2) Light, surgical, accessories (FTA) (1)

Premarket Exempt

No Yes

Clear

Aspen® Flexible Light Handle Adapter - 00887761021464 Catalog Number :

Device Description : Intent to be used with Aspen Surgical Disposable light Handle covers.

Device Class : 2

Duns Number: 027680821

Premarket Exempt : No

Product Code : FTA

Prescription Use : No

Device Count : 1

Aspen® Skin Closure - 10887761000534 Catalog Number :

Device Description : Intended for skin closure and closure support for sutures and staples

Device Class :

Duns Number: 027680821

Premarket Exempt : No

Product Code : FPX

Prescription Use : No

Device Count : 5000

Aspen® Skin Closure - 10887761000541 Catalog Number :

Device Description : Intended for skin closure and closure support for sutures and staples

Device Class :

Duns Number: 027680821

Premarket Exempt : No

Product Code : FPX

Prescription Use : No

Device Count : 5000

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