FDA.reportPublic FDA data

WishFIX

Primary DI
G791SDRASS200
Brand
WishFIX
Company
Red Star Contract Manufacturing Inc.
Model
SDRASS20
Catalog number
SDRASS20
Device description
Solid T20 Screwdriver
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
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G791SDRASS200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, single-useA non-powered tool that fits into a screw head in order to apply rotation to tighten/loosen/remove a screw during a surgical procedure. It typically has a high-grade stainless steel shaft with a distal end dedicated to fit into a screw head that may be slotted, Phillips (cross head), Pozidriv (Supadriv), Torx, Hex (Allen), Robertson (square), spanner head (twin pins), Polydrive, or one-way (clutch). The proximal end of the shaft may have a handle for manual use, or it may have a profiled tang that fits into an interchangeable screwdriver handle, a manually-operated chuck, or a power driver. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640221373076PERLA ® TLSpineArt SAHXX2026-05-07
09120125220259Shark Screw® driver aclsurgebright GmbHHXX2026-04-30
08806373894213LOSPA/BENCOXCorentec Co., LtdHXX2026-04-10
08806373899720LOSPA/BENCOXCorentec Co., LtdHXX2026-04-10
08806373887789BENCOX Surgical InstrumentsCorentec Co., LtdHXX2026-01-12
08806373892660BENCOX Surgical InstrumentsCorentec Co., LtdHXX2026-01-12
07640332475294PERLA ®SpineArt SAHXX2025-11-10
07640332475300PERLA ®SpineArt SAHXX2025-11-10
07640332475317PERLA ®SpineArt SAHXX2025-11-10
08059386744253Orthopaedic Surgical InstrumentsCITIEFFE SRLHXX2025-11-06
08059386742266Orthopaedic Surgical InstrumentsCITIEFFE SRLHXX2025-11-05
09348215164737Turbine X Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164744Turbine X Driver – RedSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164751MI (Mini Incision) Driver - RedSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164768MI (Mini Incision) Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164775O (Turbine OP) Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
093482151650172.9 Knotted DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165024Vector Knotted DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
093482151651235.5 Knotless DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165130Screw DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165178Simple Driver (Black)SIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165185Simple Driver (Orange)SIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165208Tendonesis Chamfer ReamerSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165284Staple ShaftSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
G791CDRASS200WishFIXRed Star Contract Manufacturing Inc.HXX2025-10-06
09120125220037Shark Screw® couplingsurgebright GmbHHXX2025-09-16
09120125220228Shark Screw® driversurgebright GmbHHXX2025-09-16
08800071006848Surgical InstrumentOSTEONIC CO.,Ltd.HXX2025-06-24
08800071024248SignexOSTEONIC CO.,Ltd.HXX2025-06-24
08800071024255SignexOSTEONIC CO.,Ltd.HXX2025-06-24