OAKWORKS, INC.

Address:923 E Wellspring Rd,NEW FREEDOM,PA,17349,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

Table, Cystometric, Electric (MMZ) (6) Table, Radiographic, Non-Tilting, Powered (IZZ) (6) Table, Radiographic, Stationary Top (IXQ) (6) Cradle, Patient, Radiologic (KXH) (2)

Premarket Exempt

Yes

Clear

Oakworks Medical - 00817463022476 Catalog Number :

Device Description : Carbon Fiber Arm Board, Fluoroscopy + Pad

Device Class : 2

Duns Number: 130256837

Premarket Exempt : Yes

Product Code : IZZ, MMZ, IXQ

Prescription Use : No

Device Count : 1

Oakworks Medical - 00817463022483 Catalog Number :

Device Description : Carbon Fiber Arm Board, Fluoro + Wide + Pad

Device Class : 2

Duns Number: 130256837

Premarket Exempt : Yes

Product Code : MMZ, IXQ, IZZ

Prescription Use : No

Device Count : 1

Oakworks Medical - 00817463022490 Catalog Number :

Device Description : Carbon Fiber Arm Board, Fluoro + 2" Pad + 4" Pad

Device Class : 2

Duns Number: 130256837

Premarket Exempt : Yes

Product Code : MMZ, IZZ, IXQ

Prescription Use : No

Device Count : 1

Oakworks Medical - 00817463022506 Catalog Number :

Device Description : Carbon Fiber Arm Board with 2" pad

Device Class : 2

Duns Number: 130256837

Premarket Exempt : Yes

Product Code : MMZ, IZZ, IXQ

Prescription Use : No

Device Count : 1

Oakworks Medical - 00817463022513 Catalog Number :

Device Description : Carbon Fiber Arm Board with 4" pad

Device Class : 2

Duns Number: 130256837

Premarket Exempt : Yes

Product Code : MMZ, IZZ, IXQ

Prescription Use : No

Device Count : 1

Oakworks Medical - 00817463022520 Catalog Number :

Device Description : Carbon Fiber Arm Board with 3" Pad

Device Class : 2

Duns Number: 130256837

Premarket Exempt : Yes

Product Code : MMZ, IZZ, IXQ

Prescription Use : No

Device Count : 1

Oakworks, Inc. - 00817463022537 Catalog Number :

Device Description : Spine Positioning System II Large Torso - TT

Device Class : 1

Duns Number: 130256837

Premarket Exempt : Yes

Product Code : KXH

Prescription Use : No

Device Count : 1

Oakworks, Inc. - 00817463022544 Catalog Number :

Device Description : Spine Positioning System II Large Torso - TT/EM

Device Class : 1

Duns Number: 130256837

Premarket Exempt : Yes

Product Code : KXH

Prescription Use : No

Device Count : 1

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