FDA.reportPublic FDA data

Merge OrthoTemplates

Primary DI
00842000100904
Brand
Merge OrthoTemplates
Company
MERGE HEALTHCARE SOLUTIONS INC.
Model
40.2.2
Device description
Software implant template
Published
2023-06-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00842000100904PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842000100904008420001009048420001009040842000100904

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
065626069
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842000100928Merge Cardio12.12021-09-21
00842000100850eFilm Workstation4.32021-02-08
00842000100867eFilm Lite4.32021-02-08
00842000100454Merge OrthoPACS7.1.2.12019-05-13
00842000100461Merge Unity Pacs11.02019-05-13
00842000100478Merge PACS7.1.2.12019-05-13
00842000100676Merge OrthoPACS7.22019-05-10
00842000100041Merge Cardio10.32017-01-12
00842000100058Merge Unity PACS11.1.22016-12-19
00842000100072Merge PACS7.1.12017-02-10
00842000100089Merge OrthoPACS7.1.12017-02-10
00842000100096Merge Eye Care PACS5.22016-12-01
00842000100126Merge iConnect Access6.32016-12-12
00842000100133iConnect Enterprise Workflow with Merge PACS1.02017-02-22
00842000100140Merge Eye Station11.6.12016-12-01
00842000100287eFilm Workstation4.22016-12-01
00842000100294eFilm Lite4.22016-12-01
00842000100300eFilm Lite4.2.12017-10-31
00842000100317Merge Eye Care PACS5.32017-08-24
00842000100331Merge Unity PACS11.22017-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982350596VOLTSynthes GmbHHWT2026-09-25
10886982350602VOLTSynthes GmbHHWT2026-09-25
10886982350619VOLTSynthes GmbHHWT2026-09-25
10886982350626VOLTSynthes GmbHHWT2026-09-25
10886982350695VOLTSynthes GmbHHWT2026-09-25
10886982350701VOLTSynthes GmbHHWT2026-09-25
10886982350718VOLTSynthes GmbHHWT2026-09-25
00840606191326PrimusSPINAL ELEMENTS, INC.HWT2026-09-22
03701313009502K-RODS.M.A.I.OHWT2026-09-22
00810129551846OvertureTiOverture Resurfacing IncHWT2025-07-23
00810112599534PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599541PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
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00810112599572PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599589PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599596PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599602PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599619PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599626PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599633PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599640PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599657PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599664PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599671PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599688PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599695PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599701PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599718PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-12
00810112599343PRO-SPECCROSSROADS EXTREMITY SYSTEMSHWT2025-03-07