FDA.reportPublic FDA data

NA

Primary DI
10887587056210
Brand
NA
Company
Synthes GmbH
Model
493.105
Catalog number
493105
Device description
26 GAUGE (0.4MM DIAMETER) TI WIRE WITH BARB AND NEEDLE
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAQSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, SterileGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042606000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042606000MODIFICATION TO:SYNTHES (USA) TITANIUM WIRESynthes (Usa)2005-05-27GAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887587056210PrimaryGS10
H9804931050SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088758705621010887587056210

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982342508VOLT02.535.724025357242026-09-25
10886982342515VOLT02.535.726025357262026-09-25
10886982342522VOLT02.535.728025357282026-09-25
10886982342539VOLT02.535.730025357302026-09-25
10886982342546VOLT02.535.732025357322026-09-25
10886982342553VOLT02.535.734025357342026-09-25
10886982342560VOLT02.535.736025357362026-09-25
10886982342577VOLT02.535.738025357382026-09-25
10886982342584VOLT02.535.740025357402026-09-25
10886982342591VOLT02.535.742025357422026-09-25
10886982342607VOLT02.535.744025357442026-09-25
10886982342614VOLT02.535.746025357462026-09-25
10886982342621VOLT02.535.748025357482026-09-25
10886982342638VOLT02.535.750025357502026-09-25
10886982342645VOLT02.535.752025357522026-09-25
10886982342652VOLT02.535.754025357542026-09-25
10886982342669VOLT02.535.756025357562026-09-25
10886982342676VOLT02.535.758025357582026-09-25
10886982342683VOLT02.535.760025357602026-09-25
10886982344878VOLT02.535.765025357652026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10652927785309DemeSTEELDemetech CorporationGAQ2023-08-22
10652927786085DemeSTEELDemetech CorporationGAQ2023-08-22
10652927786092DemeSTEELDemetech CorporationGAQ2023-08-22
10652927777823DemeSTEELDemetech CorporationGAQ2022-12-21
10652927782926DemeSTEELDemetech CorporationGAQ2022-12-21
10652927783176DemeSTEELDemetech CorporationGAQ2022-12-21
10652927783183DemeSTEELDemetech CorporationGAQ2022-12-21
10652927783190DemeSTEELDemetech CorporationGAQ2022-12-21
10652927783206DemeSTEELDemetech CorporationGAQ2022-12-21
10652927722694DemeSTEELDemetech CorporationGAQ2020-10-13
10652927697220DemeSTEELDemetech CorporationGAQ2020-01-15
10652927669869DemeSTEELDemetech CorporationGAQ2019-12-24
10652927669876DemeSTEELDemetech CorporationGAQ2019-12-24
10652927684169DemeSTEELDemetech CorporationGAQ2019-12-24
10652927151050DemeSTEELDemetech CorporationGAQ2019-07-11
10652927161042DemeSTEELDemetech CorporationGAQ2019-07-11
10652927161172DemeSTEELDemetech CorporationGAQ2019-07-11
10652927164265DemeSTEELDemetech CorporationGAQ2019-07-11
10652927164371DemeSTEELDemetech CorporationGAQ2019-07-11
10652927165026DemeSTEELDemetech CorporationGAQ2019-07-11
10652927165033DemeSTEELDemetech CorporationGAQ2019-07-11
10652927165576DemeSTEELDemetech CorporationGAQ2019-07-11
10652927174226DemeSTEELDemetech CorporationGAQ2019-07-11
10652927174233DemeSTEELDemetech CorporationGAQ2019-07-11
10652927176909DemeSTEELDemetech CorporationGAQ2019-07-11
10652927207382DemeSTEELDemetech CorporationGAQ2019-07-11
10652927216797DemeSTEELDemetech CorporationGAQ2019-07-11
10652927216841DemeSTEELDemetech CorporationGAQ2019-07-11
10652927219736DemeSTEELDemetech CorporationGAQ2019-07-11
10652927219743DemeSTEELDemetech CorporationGAQ2019-07-11