FDA.reportPublic FDA data

gSource

Primary DI
M7557891160
Brand
gSource
Company
GSOURCE LLC
Model
gS 78.9116
Catalog number
gS 78.9116
Device description
"K-Wire S. Trocar 25mm Thr. 9"" 1.6mm [.062""] pkg/6"
Published
2021-07-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HXSTwister, Wire

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXSTwister, WireOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7557891160PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Wire/ligature passer, reusableA hand-held, manual surgical instrument designed for passing a length of a flexible material/device, typically a wire, ligature, or orthopaedic graft gauge, through a surgical site by creating a pathway through tissue and facilitating the introduction and handling of the material/device. It may also be referred to as a carrier and is typically in the form of a shaft with a distal clasp, grasping arm, or cannulated hook to hold the material being passed through the tissue. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
008162518
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840314265241gSourcegS 86.9711gS 86.97112024-12-06
00840314216854gSourcegS 40.1100gS 40.11002019-12-17
00840314270276gSourcegS 33.0310gS 33.03102026-05-20
00840314270283gSourcegS 33.0311gS 33.03112026-05-20
00840314270221gSourcegS 82.7715gS 82.77152026-03-20
00840314270238gSourcegS 82.7717gS 82.77172026-03-20
00840314270245gSourcegS 86.8120gS 86.81202026-03-20
00840314270252gSourcegS 86.8125gS 86.81252026-03-20
00840314270269gSourcegS 86.8130gS 86.81302026-03-20
00840314238511gSourcegS 75.3124gS 75.31242025-11-24
00840314238528gSourcegS 75.3250gS 75.32502025-11-24
00840314238535gSourcegS 75.3280gS 75.32802025-11-24
00840314238542gSourcegS 75.9230gS 75.92302025-11-24
00840314238559gSourcegS 75.9240gS 75.92402025-11-24
00840314238566gSourcegS 75.9250gS 75.92502025-11-24
00840314238573gSourcegS 75.9255gS 75.92552025-11-24
00840314238580gSourcegS 75.9260gS 75.92602025-11-24
00840314238597gSourcegS 75.9282gS 75.92822025-11-24
00840314238603gSourcegS 75.9300gS 75.93002025-11-24
00840314238610gSourcegS 75.9302gS 75.93022025-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811105868INKAThe Trustee for KAISER FAMILY TRUSTHXS2026-06-02
09348811166029INKAThe Trustee for KAISER FAMILY TRUSTHXS2026-05-29
04052536085330neon3Ulrich GmbH & Co. KGHXS2026-05-28
04052536085361neon3Ulrich GmbH & Co. KGHXS2026-05-28
B8034803200ORTHOMEDORTHO-MED, INC.HXS2026-04-16
B8034803220ORTHOMEDORTHO-MED, INC.HXS2026-04-16
B8034803240ORTHOMEDORTHO-MED, INC.HXS2026-04-16
00888867500730Arthrex®ARTHREX, INC.HXS2026-03-13
00888867500747Arthrex®ARTHREX, INC.HXS2026-03-13
09348811105875INKAThe Trustee for KAISER FAMILY TRUSTHXS2025-11-26
04052536081097uCentumUlrich GmbH & Co. KGHXS2025-07-29
04052536081103uCentumUlrich GmbH & Co. KGHXS2025-07-29
04052536010585uCentumUlrich GmbH & Co. KGHXS2025-07-24
00190776394073MillenniumAvalign Technologies, Inc.HXS2025-05-06
00192896121379Wire TwisterSONTEC INSTRUMENTS, INC.HXS2025-04-11
00190776387372MillenniumAvalign Technologies, Inc.HXS2024-09-09
04049197086950RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHXS2024-06-25
00192896116887Axel Wire Twister/CutterSONTEC INSTRUMENTS, INC.HXS2024-03-08
00888515056404BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.HXS2024-02-28
00888515204638BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.HXS2024-02-28
00888515204645BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.HXS2024-02-28
00888515204652BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.HXS2024-02-28
00888515204669BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.HXS2024-02-28
00888515204683BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.HXS2024-02-28
10840199532510Rod Holder ClampKOROS U.S.A., INC.HXS2024-01-31
00840199532513Rod Holder ClampKOROS U.S.A., INC.HXS2024-01-31
G586N2567460Novo SurgicalNOVO SURGICAL, INC.HXS2023-12-18
G586N8716610Novo SurgicalNOVO SURGICAL, INC.HXS2023-12-18
G586N98716620Novo SurgicalNOVO SURGICAL, INC.HXS2023-12-18
00192896115828Wire TwisterSONTEC INSTRUMENTS, INC.HXS2023-11-16