Schaerer Medical Usa, Inc.

Address:Erlenauweg 17,Muensingen Bern,CH

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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

Operating Room Accessories Table Tray (FWZ) (10) Table, Surgical With Orthopedic Accessories, Manual (JEB) (1)

Premarket Exempt

Yes

Clear

Schaerer Medical USA - 10810101300438 Catalog Number : 10373

Device Description : DISPOSABLE PERINEAL POST PAD 7" STD. (2") Post 1 Dozen DISPOSABLE PERINEAL POST PAD 7" STD. (2") Post 1 Dozen

Device Class : 1

Duns Number: 092820703

Premarket Exempt : Yes

Product Code : FWZ

Prescription Use : No

Device Count : 12

Schaerer Medical USA - 10810101300445 Catalog Number :

Device Description : DISPOSABLE PERINEAL POST PAD 9" STD. (2") Post 1 Dozen

Device Class : 1

Duns Number: 092820703

Premarket Exempt : Yes

Product Code : FWZ

Prescription Use : No

Device Count : 12

Schaerer Medical USA - 10810101300452 Catalog Number : 10375

Device Description : DISPOSABLE PERINEAL POST PAD 9" Firm (1-1/2") Post 1 Dozen

Device Class : 1

Duns Number: 092820703

Premarket Exempt : Yes

Product Code : FWZ

Prescription Use : No

Device Count : 12

Schaerer Medical USA - 10810101300469 Catalog Number : 10376

Device Description : DISPOSABLE PERINEAL POST PAD 9" Firm (2") Post 1 Dozen

Device Class : 1

Duns Number: 092820703

Premarket Exempt : Yes

Product Code : FWZ

Prescription Use : No

Device Count : 12

Schaerer Medical USA - 10810101300476 Catalog Number : 10377

Device Description : DISPOSABLE PERINEAL POST PAD 7" Firm (1-1/2") Post 1 Dozen

Device Class : 1

Duns Number: 092820703

Premarket Exempt : Yes

Product Code : FWZ

Prescription Use : No

Device Count : 12

Schaerer Medical USA - 10810101300483 Catalog Number : 10379

Device Description : DISPOSABLE HEEL REST PAD (12 Pair) DISPOSABLE HEEL REST PAD (12 Pair)

Device Class : 1

Duns Number: 092820703

Premarket Exempt : Yes

Product Code : FWZ

Prescription Use : No

Device Count : 12

Schaerer Medical USA - 10810101300490 Catalog Number : 10522

Device Description : DISPOSABLE PAD SET (12 SETS) DISPOSABLE PAD SET (12 SETS)

Device Class : 1

Duns Number: 092820703

Premarket Exempt : Yes

Product Code : FWZ

Prescription Use : No

Device Count : 12

Schaerer Medical USA - 10810101300506 Catalog Number : 10940

Device Description : TRACTION BOOT SOCK INSERT

Device Class : 1

Duns Number: 092820703

Premarket Exempt : Yes

Product Code : JEB, FWZ

Prescription Use : No

Device Count : 5

Schaerer Medical USA - 10810101300520 Catalog Number : 13115

Device Description : MLPD DISPOSABLE PAD (6' ROLL) 3 ROLLS

Device Class : 1

Duns Number: 092820703

Premarket Exempt : Yes

Product Code : FWZ

Prescription Use : No

Device Count : 3

Schaerer Medical USA - 10810101300551 Catalog Number : 10820

Device Description : Table Cushion Set

Device Class : 1

Duns Number: 092820703

Premarket Exempt : Yes

Product Code : FWZ

Prescription Use : No

Device Count : 5

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