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) (9) Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate (MEH) (9) Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer (KRR) (1)

Premarket Exempt

Clear

Paragon - 09340499002125 Catalog Number : GM08001-206-11

Device Description : Paragon Stem Standard Sz 11 HA

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

Paragon - 09340499002132 Catalog Number : GM08001-206-12

Device Description : Paragon Stem Standard Sz 12 HA

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

Paragon - 09340499002149 Catalog Number : GM08001-208-01

Device Description : Paragon Stem High Offset Sz 1 HA

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

Paragon - 09340499002156 Catalog Number : GM08001-208-02

Device Description : Paragon Stem High Offset Sz 2 HA

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

Paragon - 09340499002163 Catalog Number : GM08001-208-03

Device Description : Paragon Stem High Offset Sz 3 HA

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

Paragon - 09340499002170 Catalog Number : GM08001-208-04

Device Description : Paragon Stem High Offset Sz 4 HA

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

Paragon - 09340499002187 Catalog Number : GM08001-208-05

Device Description : Paragon Stem High Offset Sz 5 HA

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

Paragon - 09340499002194 Catalog Number : GM08001-208-06

Device Description : Paragon Stem High Offset Sz 6 HA

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

Paragon - 09340499002200 Catalog Number : GM08001-208-07

Device Description : Paragon Stem High Offset Sz 7 HA

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

RBK Patella Femoral - 09340499004624 Catalog Number : GO-1003-24-00

Device Description : RBK Patella 24mm

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : KRR

Prescription Use : Yes

Device Count : 1

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