OSSAWARE BIOTECH CO., LTD.

Address:No. 51, Xinggong Rd.,,Shenkang Hsiang Changhua,TW

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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

Cover, Burr Hole (GXR) (4) Accessory, Surgical Apparel (LYU) (1)

Premarket Exempt

No Yes

Clear

CirFIX® Cranial bone fixation system: Flap Fixator - 04717002404168 Catalog Number : 9903.0001.15S

Device Description : CUSMED Flap Fixator, Low Profile Replaceable Type+Screwdriver, PEEK, D15mm, Sterile

Device Class :

Duns Number: 656747172

Premarket Exempt : No

Product Code : GXR

Prescription Use : Yes

Device Count : 1

CirFIX® Cranial bone fixation system: Flap Fixator (3 PCS) - 04717002404175 Catalog Number : 9903.0101.15S

Device Description : CUSMED Flap Fixator, Low Profile Replaceable Type+Screwdriver, PEEK, D15mm, Ster CUSMED Flap Fixator, Low Profile Replaceable Type+Screwdriver, PEEK, D15mm, Sterile (3 PCS)

Device Class :

Duns Number: 656747172

Premarket Exempt : No

Product Code : GXR

Prescription Use : Yes

Device Count : 1

CirFIX® Cranial bone fixation system: Burr Hole Cover - 04717002404328 Catalog Number : 9905.0014.11S

Device Description : CUSMED CirFIX® Burr Hole Cover, Radiolucent Revisable Type+Screwdriver, PEEK, 14 CUSMED CirFIX® Burr Hole Cover, Radiolucent Revisable Type+Screwdriver, PEEK, 14mm/11mm, Sterile

Device Class :

Duns Number: 656747172

Premarket Exempt : No

Product Code : GXR

Prescription Use : Yes

Device Count : 1

CirFIX® Cranial bone fixation system: Burr Hole Cover - 04717002404335 Catalog Number : 9906.0014.11S

Device Description : CUSMED CirFIX® Burr Hole Cover, Radiolucent Revisable Type for Shunt & ICP+Screw CUSMED CirFIX® Burr Hole Cover, Radiolucent Revisable Type for Shunt & ICP+Screwdriver, PEEK, 14mm/11mm, Sterile

Device Class :

Duns Number: 656747172

Premarket Exempt : No

Product Code : GXR

Prescription Use : Yes

Device Count : 1

CUSMED FACE MASK - 04717002404380 Catalog Number :

Device Description : 3 Ply - Disposable High Filtration Face Mask • Face Mask Size: 175mm x 95mm (± 3 Ply - Disposable High Filtration Face Mask • Face Mask Size: 175mm x 95mm (± 5 mm) • Non - sterile, single use

Device Class :

Duns Number: 656747172

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : No

Device Count : 1

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