FDA.reportPublic FDA data

Surgical Template

Primary DI
09349797000093
Brand
Surgical Template
Company
ANATOMICS PTY LTD
Model
TP-BRT
Catalog number
TP-BRT
Device description
Surgical Template - BRT
Published
2020-11-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWTTemplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09349797000093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09349797000093093497970000939349797000093

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, single-useA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
755739307
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09349797001366Surgical BioModelBM-IMPLANTBM-IMPLANT2020-01-08
09349797002530StarPoreCI-STARPORE-S2CI-STARPORE-S22020-04-03
09349797002547StarPoreCI-STARPORE-M2CI-STARPORE-M22020-04-03
09349797002554StarPoreCI-STARPORE-L2CI-STARPORE-L22020-04-03
09349797002561StarPoreCI-STARPORE-XL2CI-STARPORE-XL22020-04-03
09349797001700StarPoreCI-STARPORE-OTCI-STARPORE-OT2020-02-17
09349797002387StarPoreCI-STARPORE-SAMPLECI-STARPORE-SAMPLE2020-02-10
09349797000192StarPoreCI-STARPORE-SCI-STARPORE-S2020-01-08
09349797000208StarPoreCI-STARPORE-MCI-STARPORE-M2020-01-08
09349797000215StarPoreCI-STARPORE-LCI-STARPORE-L2020-01-08
09349797000222StarPoreCI-STARPORE-XLCI-STARPORE-XL2020-01-08
09349797000239StarPoreCI-STARPORE-OCI-STARPORE-O2020-01-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606191326PrimusSPINAL ELEMENTS, INC.HWT2026-09-22
03701313009502K-RODS.M.A.I.OHWT2026-09-22
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