PRESERVATION SOLUTIONS INC

Address:1099 Proctor Dr,ELKHORN,WI,53121,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

Retention Device, Suture (KGS) (3) Anti Fog Solution And Accessories, Endoscopy (OCT) (2)

Premarket Exempt

No Yes

Clear

StarGuard Suture Retention Plates - 7" - 00810805000224 Catalog Number :

Device Description : For the temporary, external anchoring of sutures and prevention of suture pull through.

Device Class : 1

Duns Number: 090266979

Premarket Exempt : Yes

Product Code : KGS

Prescription Use : No

Device Count : 1

StarGuard Suture Retention Plates - 9" - 00810805000231 Catalog Number :

Device Description : For the temporary, external anchoring of sutures and prevention of suture pull through.

Device Class : 1

Duns Number: 090266979

Premarket Exempt : Yes

Product Code : KGS

Prescription Use : No

Device Count : 1

ClearIt Anti-Fog Cloth - 10810805000139 Catalog Number :

Device Description : A sterile low-linting cloth pre-saturated with anti-fog solution.

Device Class :

Duns Number: 090266979

Premarket Exempt : No

Product Code : OCT

Prescription Use : No

Device Count : 20

ClearIt Anti-Fog Kit - 10810805000146 Catalog Number :

Device Description : A sterile kit containing a 6cc vial of anti-fog solution and sponge with radiopa A sterile kit containing a 6cc vial of anti-fog solution and sponge with radiopaque marker, pack of 10

Device Class :

Duns Number: 090266979

Premarket Exempt : No

Product Code : OCT

Prescription Use : No

Device Count : 10

Retention Guard Suture Retention Plates - 3" - 10810805000214 Catalog Number :

Device Description : For the temporary, external anchoring of sutures and prevention of suture pull through.

Device Class :

Duns Number: 090266979

Premarket Exempt : Yes

Product Code : KGS

Prescription Use : No

Device Count : 10

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