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) (5) Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate (MEH) (5) Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer (KRR) (4) Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer (HRY) (1)

Premarket Exempt

Clear

RBK Patello Femoral - 09340499004631 Catalog Number : GO-1003-28-00

Device Description : RBK Patella 28mm

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : KRR

Prescription Use : Yes

Device Count : 1

RBK Patello Femoral - 09340499004648 Catalog Number : GO-1003-32-00

Device Description : RBK Patella 32mm

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : KRR

Prescription Use : Yes

Device Count : 1

RBK Patello Femoral - 09340499004655 Catalog Number : GO-1003-36-00

Device Description : RBK Patella 36mm

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : KRR

Prescription Use : Yes

Device Count : 1

RBK Patello Femoral - 09340499004662 Catalog Number : GO-1003-40-00

Device Description : RBK Patella 40mm

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : KRR

Prescription Use : Yes

Device Count : 1

Paragon - 09340499004693 Catalog Number : GM08001-208-08

Device Description : Paragon Stem High Offset Sz 8 HA

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

Paragon - 09340499004716 Catalog Number : GM08001-208-09

Device Description : Paragon Stem High Offset Sz 9 HA

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

Paragon - 09340499005041 Catalog Number : GM08001-208-10

Device Description : Paragon Stem High Offset Sz 10 HA

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

Paragon - 09340499005119 Catalog Number : GM08001-208-11

Device Description : Paragon Stem High Offset Sz 11 HA

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

Paragon - 09340499005126 Catalog Number : GM08001-208-12

Device Description : Paragon Stem High Offset Sz 12 HA

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : LZO, MEH

Prescription Use : Yes

Device Count : 1

GRU Tibia - 09340499005195 Catalog Number : GRU-0T-6.5-P-R

Device Description : GRU Tibia Size 0 6.5mm

Device Class : 2

Duns Number: 752039982

Premarket Exempt : No

Product Code : HRY

Prescription Use : Yes

Device Count : 1

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