FDA.reportPublic FDA data

WishFIX

Primary DI
G79153202021615G0
Brand
WishFIX
Company
Red Star Contract Manufacturing Inc.
Model
53-202-021615G
Catalog number
53-202-021615G
Device description
WishFIX 1.6mm x 152mm Threaded Guide Wire
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
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G79153202021615G0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, single-useA hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. 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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Primary DI, Brand, Company table
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