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 - 09340499024684 Catalog Number : GM08001-322-04

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

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : MEH, LZO

Prescription Use : Yes

Device Count : 1

Paragon - 09340499024691 Catalog Number : GM08001-322-05

Device Description : Paragon Trial Neck High Offset 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 - 09340499024707 Catalog Number : GM08001-322-06

Device Description : Paragon Trial Neck High Offset 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 - 09340499024714 Catalog Number : GM08001-322-07

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

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

Paragon - 09340499024721 Catalog Number : GM08001-349-01

Device Description : Paragon Distal Broach Size 1 - Male (Omni)

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

Paragon - 09340499024738 Catalog Number : GM08001-349-02

Device Description : Paragon Distal Broach Size 2 - Male (Omni)

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : MEH, LZO

Prescription Use : Yes

Device Count : 1

Paragon - 09340499024745 Catalog Number : GM08001-349-03

Device Description : Paragon Distal Broach Size 3 - Male (Omni)

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : MEH, LZO

Prescription Use : Yes

Device Count : 1

Paragon - 09340499024752 Catalog Number : GM08001-349-04

Device Description : Paragon Distal Broach Size 4 - Male (Omni)

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : MEH, LZO

Prescription Use : Yes

Device Count : 1

Paragon - 09340499024769 Catalog Number : GM08001-349-05

Device Description : Paragon Distal Broach Size 5 - Male (Omni)

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : MEH, LZO

Prescription Use : Yes

Device Count : 1

Paragon - 09340499024776 Catalog Number : GM08001-349-06

Device Description : Paragon Distal Broach Size 6 - Male (Omni)

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

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