ANATOMICS PTY LTD

Address:Warehouse 1,Bentleigh East Victoria,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

Plate, Cranioplasty, Preformed, Alterable (GWO) (8) Polymer, Ent Synthetic, Porous Polyethylene (JOF) (8) Template (HWT) (2)

Premarket Exempt

No Yes

Clear

Surgical Template - 09349797000093 Catalog Number : TP-BRT

Device Description : Surgical Template - BRT

Device Class : 1

Duns Number: 755739307

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : Yes

Device Count : 1

StarPore - 09349797000192 Catalog Number : CI-STARPORE-S

Device Description : StarPore Patient Specific Implant (Small)

Device Class : 2

Duns Number: 755739307

Premarket Exempt : No

Product Code : GWO, JOF

Prescription Use : Yes

Device Count : 1

StarPore - 09349797000208 Catalog Number : CI-STARPORE-M

Device Description : StarPore Patient Specific Implant (Medium)

Device Class : 2

Duns Number: 755739307

Premarket Exempt : No

Product Code : JOF, GWO

Prescription Use : Yes

Device Count : 1

StarPore - 09349797000215 Catalog Number : CI-STARPORE-L

Device Description : StarPore Patient Specific Implant (Large)

Device Class : 2

Duns Number: 755739307

Premarket Exempt : No

Product Code : GWO, JOF

Prescription Use : Yes

Device Count : 1

StarPore - 09349797000222 Catalog Number : CI-STARPORE-XL

Device Description : StarPore Patient Specific Implant (X-Large)

Device Class : 2

Duns Number: 755739307

Premarket Exempt : No

Product Code : JOF, GWO

Prescription Use : Yes

Device Count : 1

StarPore - 09349797000239 Catalog Number : CI-STARPORE-O

Device Description : StarPore Patient Specific Implant (Other)

Device Class : 2

Duns Number: 755739307

Premarket Exempt : No

Product Code : GWO, JOF

Prescription Use : Yes

Device Count : 1

Surgical BioModel - 09349797001366 Catalog Number : BM-IMPLANT

Device Description : Biomodel for implant reference

Device Class : 1

Duns Number: 755739307

Premarket Exempt : No

Product Code : HWT

Prescription Use : Yes

Device Count : 1

StarPore - 09349797001700 Catalog Number : CI-STARPORE-OT

Device Description : StarPore Patient Specific Implant

Device Class : 2

Duns Number: 755739307

Premarket Exempt : No

Product Code : GWO, JOF

Prescription Use : Yes

Device Count : 1

StarPore - 09349797002387 Catalog Number : CI-STARPORE-SAMPLE

Device Description : StarPore Patient Specific Implant (SAMPLE)

Device Class : 2

Duns Number: 755739307

Premarket Exempt : No

Product Code : GWO, JOF

Prescription Use : Yes

Device Count : 1

StarPore - 09349797002530 Catalog Number : CI-STARPORE-S2

Device Description : StarPore Patient Specific Implant (Small)

Device Class : 2

Duns Number: 755739307

Premarket Exempt : No

Product Code : GWO, JOF

Prescription Use : Yes

Device Count : 1

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