GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED

Address:17 Bridge Street,Pymble New South Wales,AU

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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

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (LZO) (10) Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate (MEH) (10)

Premarket Exempt

Clear

Paragon - 09340499024585 Catalog Number : GM08001-321-07

Device Description : Paragon Broach, Size 7 - Male (OMNI)

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

Paragon - 09340499024592 Catalog Number : GM08001-321-08

Device Description : Paragon Broach, Size 8- Male (OMNI)

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

Paragon - 09340499024608 Catalog Number : GM08001-321-09

Device Description : Paragon Broach, Size 9 - Male (OMNI)

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

Paragon - 09340499024615 Catalog Number : GM08001-321-10

Device Description : Paragon Broach, Size 10 - Male (OMNI)

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

Paragon - 09340499024622 Catalog Number : GM08001-321-11

Device Description : Paragon Broach, Size 11 - Male (OMNI)

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

Paragon - 09340499024639 Catalog Number : GM08001-321-12

Device Description : Paragon Broach, Size 12 - Male (OMNI)

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

Paragon - 09340499024646 Catalog Number : GM08001-322-00

Device Description : Paragon Trial Neck Standard Size 1 - 3 - Female (Omni)

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

Paragon - 09340499024653 Catalog Number : GM08001-322-01

Device Description : Paragon Trial Neck Standard Size 4 - 6 - Female (Omni)

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

Paragon - 09340499024660 Catalog Number : GM08001-322-02

Device Description : Paragon Trial Neck Standard Size 7 - 9 - Female (Omni)

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : MEH, LZO

Prescription Use : Yes

Device Count : 1

Paragon - 09340499024677 Catalog Number : GM08001-322-03

Device Description : Paragon Trial Neck Standard Size 10 - 12 - Female (Omni)

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

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