ASTON MEDICAL

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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, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate (MEH) (10)

Premarket Exempt

Clear

TREGOR® - 03663703000103 Catalog Number : 12581970U

Device Description : Uncemented standard cup

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : MEH

Prescription Use : Yes

Device Count : 1

TREGOR® - 03663703000110 Catalog Number : 12601970U

Device Description : Uncemented standard cup

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : MEH

Prescription Use : Yes

Device Count : 1

TREGOR® - 03663703000127 Catalog Number : 12621970U

Device Description : Uncemented standard cup

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : MEH

Prescription Use : Yes

Device Count : 1

TREGOR® - 03663703000134 Catalog Number : 12521978U

Device Description : Uncemented 3 blades cup

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : MEH

Prescription Use : Yes

Device Count : 1

TREGOR® - 03663703000141 Catalog Number : 12541978U

Device Description : Uncemented 3 blades cup

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : MEH

Prescription Use : Yes

Device Count : 1

TREGOR® - 03663703000158 Catalog Number : 12561978U

Device Description : Uncemented 3 blades cup

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : MEH

Prescription Use : Yes

Device Count : 1

TREGOR® - 03663703000165 Catalog Number : 12581978U

Device Description : Uncemented 3 blades cup

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : MEH

Prescription Use : Yes

Device Count : 1

TREGOR® - 03663703000172 Catalog Number : 12601978U

Device Description : Uncemented 3 blades cup

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : MEH

Prescription Use : Yes

Device Count : 1

TREGOR® - 03663703000189 Catalog Number : 12621978U

Device Description : Uncemented 3 blades cup

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : MEH

Prescription Use : Yes

Device Count : 1

TREGOR® - 03663703000196 Catalog Number : 12528970U

Device Description : Uncemented + cup

Device Class : 2

Duns Number: 576503098

Premarket Exempt : No

Product Code : MEH

Prescription Use : Yes

Device Count : 1

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