DSM BIOMEDICAL, INC.

Address:735 Pennsylvania Dr,EXTON,PA,19341,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

Bit, Drill (HTW) (7) Trephine (HWK) (7) Tamp (HXG) (2) Filler, Bone Void, Calcium Compound (MQV) (1)

Premarket Exempt

No Yes

Clear

ProChondrix® Instrument Set - 00812337021203 Catalog Number :

Device Description : Single-use disposable orthopedic manual surgical instrument sets

Device Class : 1

Duns Number: 131107757

Premarket Exempt : Yes

Product Code : HTW, HWK

Prescription Use : Yes

Device Count : 1

ProChondrix® Instrument Set - 00812337021210 Catalog Number :

Device Description : Single-use disposable orthopedic manual surgical instrument set

Device Class : 1

Duns Number: 131107757

Premarket Exempt : Yes

Product Code : HWK, HTW

Prescription Use : Yes

Device Count : 1

ProChondrix® Instrument Set - 00812337021227 Catalog Number :

Device Description : Single-use disposable orthopedic manual surgical instrument set

Device Class : 1

Duns Number: 131107757

Premarket Exempt : Yes

Product Code : HTW, HWK

Prescription Use : Yes

Device Count : 1

ProChondrix® Instrument Set - 00812337021234 Catalog Number :

Device Description : Single-use disposable orthopedic manual surgical instrument set

Device Class : 1

Duns Number: 131107757

Premarket Exempt : Yes

Product Code : HWK, HTW

Prescription Use : Yes

Device Count : 1

ProChondrix® Instrument Set - 00812337021241 Catalog Number :

Device Description : Single-use disposable orthopedic manual surgical instrument set

Device Class : 1

Duns Number: 131107757

Premarket Exempt : Yes

Product Code : HTW, HWK

Prescription Use : Yes

Device Count : 1

ProChondrix® Instrument Set - 00812337021258 Catalog Number :

Device Description : Single-use disposable orthopedic manual surgical instrument set

Device Class : 1

Duns Number: 131107757

Premarket Exempt : Yes

Product Code : HWK, HTW

Prescription Use : Yes

Device Count : 1

ProChondrix® Instrument Set - 00812337021265 Catalog Number :

Device Description : Single-use disposable orthopedic manual surgical instrument set

Device Class : 1

Duns Number: 131107757

Premarket Exempt : Yes

Product Code : HTW, HWK

Prescription Use : Yes

Device Count : 1

ProChondrix® Sizer Set - 00812337021272 Catalog Number :

Device Description : Single-use disposable orthopedic manual surgical instrument set

Device Class : 1

Duns Number: 131107757

Premarket Exempt : Yes

Product Code : HXG

Prescription Use : Yes

Device Count : 1

ProChondrix® Sizer Set - 00812337021289 Catalog Number :

Device Description : Single-use disposable orthopedic manual surgical instrument set

Device Class : 1

Duns Number: 131107757

Premarket Exempt : Yes

Product Code : HXG

Prescription Use : Yes

Device Count : 1

Osseofit™ Porous Tissue Matrix - 00812337021517 Catalog Number : 50604-04

Device Class : 2

Duns Number: 131107757

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

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