FDA.reportPublic FDA data

WishFIX

Primary DI
G791EFTEMPS080
Brand
WishFIX
Company
Red Star Contract Manufacturing Inc.
Model
EFTEMPS-08
Catalog number
EFTEMPS-08
Device description
WishFIX Templates, 3 pack
Published
2025-10-06
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

Contact Domains#

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
G791EFTEMPS080PrimaryHIBCC0

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.

Contacts#

Phone, Email table
PhoneEmail
(260) 327-3145customerservice@redstarcontractmfg.com

Regulatory Flags#

DUNS number
968145917
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G791EFC0212S080WishFIXEFC0212S-08EFC0212S-082025-10-06
G791EFC0212T080WishFIXEFC0212T-08EFC0212T-082025-10-06
G791EFC0216S080WishFIXEFC0216S-08EFC0216S-082025-10-06
G791EFC0216T080WishFIXEFC0216T-08EFC0216T-082025-10-06
G791EFC0220S080WishFIXEFC0220S-08EFC0220S-082025-10-06
G791EFC0220T080WishFIXEFC0220T-08EFC0220T-082025-10-06
G791EFC0222S080WishFIXEFC0222S-08EFC0222S-082025-10-06
G791EFC0222T080WishFIXEFC0222T-08EFC0222T-082025-10-06
G791EFC0224T080WishFIXEFC0224T-08EFC0224T-082025-10-06
G791EFC0422T080WishFIXEFC0422T-08EFC0422T-082025-10-06
G791EFC0426S080WishFIXEFC0426S-08EFC0426S-082025-10-06
G791EFC0432S080WishFIXEFC0432S-08EFC0432S-082025-10-06
G791PKEFC0212S080WishFIXPK-EFC0212S-08PK-EFC0212S-082025-10-06
G791PKEFC0422S080WishFIXPK-EFC0422S-08PK-EFC0422S-082025-10-06
G791SEFSS16080WishFIXSEFSS16-08SEFSS16-082025-10-06
G791SEFSS20080WishFIXSEFSS20-08SEFSS20-082025-10-06
G791SEFSS24080WishFIXSEFSS24-08SEFSS24-082025-10-06
G791SEFSS28080WishFIXSEFSS28-08SEFSS28-082025-10-06
G791SEFSS32080WishFIXSEFSS32-08SEFSS32-082025-10-06
G791SEFSS36080WishFIXSEFSS36-08SEFSS36-082025-10-06

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