gSource

Primary DI
M7557820501
Brand
gSource
Company
GSOURCE LLC
Model
78.2050
Catalog number
gS 78.2050
Device description
"K-Wire D. Trocar 5"" 0.7mm [.028""] pkg/6"
Published
2017-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KDWContainer, Specimen Mailer And Storage, Temperature Controlled, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDWContainer, Specimen Mailer And Storage, Temperature Controlled, SterilePathology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100736000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100736000KIRSCHNER AND GUIDE WIRESSmt Schilling Metalltechnik GmbH2010-09-10HTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7557820501PrimaryHIBCC0
M7557820500Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone wireA wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
008162518
Device count
6
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840314270290gSourcegS 51.7750gS 51.77502026-08-07
00840314269751gSourcegS 53.4800gS 53.48002025-06-16
00840314269737gSourcegS 81.8607gS 81.86072025-05-05
00840314269584gSourcegS 82.7910gS 82.79102024-05-22
00840314263261gSourcegS 86.7506gS 86.75062026-07-24
00840314263278gSourcegS 86.7516gS 86.75162026-07-24
00840314263285gSourcegS 86.7571gS 86.75712026-07-24
00840314263353gSourcegS 86.7581gS 86.75812026-07-24
00840314263421gSourcegS 86.7591gS 86.75912026-07-24
00840314263704gSourcegS 86.9401gS 86.94012026-07-24
00840314263773gSourcegS 86.9451gS 86.94512026-07-24
00840314263841gSourcegS 86.9461gS 86.94612026-07-24
00840314233066gSourcegS 65.7431gS 65.74312020-02-18
00840314263636gSourcegS 86.9391gS 86.93912026-07-17
00840314264190gSourcegS 86.9521gS 86.95212026-07-17
00840314264268gSourcegS 86.9531gS 86.95312026-07-17
00840314264404gSourcegS 86.9551gS 86.95512026-07-17
00840314264473gSourcegS 86.9561gS 86.95612026-07-17
00840314264541gSourcegS 86.9571gS 86.95712026-07-17
00840314264619gSourcegS 86.9581gS 86.95812026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850037506207Skin Biopsy Transport KitVERICEL CORPORATIONKDW2022-12-08
00850037506194Cartilage Biopsy Transport KitVERICEL CORPORATIONKDW2022-12-08
00860004093008Skin Biopsy Transport KitVERICEL CORPORATIONKDW2020-09-24
00860004093015Cartilage Biopsy Transport KitVERICEL CORPORATIONKDW2020-09-24