FDA.reportPublic FDA data

NA

Primary DI
03596010103895
Brand
NA
Company
Smith & Nephew, Inc.
Model
220168
Catalog number
220168
Device description
SUTURE WIRE 18 GA
Published
2015-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDQCERCLAGE, FIXATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDQCerclage, FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010103895PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010103895035960101038953596010103895

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)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556919712Real IntelligenceROB30001ROB300012026-03-10
00885556919729Real IntelligenceROB30002ROB300022026-03-10
00885556919743Real IntelligenceROB30003ROB300032026-03-10
00885556919750Real IntelligenceROB30004ROB300042026-03-10
00885556919767Real IntelligenceROB30005ROB300052026-03-10
00885556919774Real IntelligenceROB30006ROB300062026-03-10
00885556924198Real IntelligenceROB30026ROB300262026-03-10
00885556924204Real IntelligenceROB30021ROB300212026-03-10
00885556924211Real IntelligenceROB30027ROB300272026-03-10
00885556924228Real IntelligenceROB30022ROB300222026-03-10
00885556924235Real IntelligenceROB30023ROB300232026-03-10
00885556924242Real IntelligenceROB30024ROB300242026-03-10
00885556924266Real IntelligenceROB30028ROB300282026-03-10
00885556924273Real IntelligenceROB30020ROB300202026-03-10
00885556924297Real IntelligenceROB30880ROB308802026-03-10
20885556924307NAROB30031ROB300312026-03-10
00885556787786NA74034136740341362026-02-20
00885556884027NA74038834740388342026-02-20
00885556884034NA74038835740388352026-02-20
00885556884140NA74038846740388462026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867525931Arthrex®ARTHREX, INC.JDQ2025-10-20
07899258696942Stitch Cerclage - Suture TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2025-08-25
07899258696959Stitch Cerclage - Suture TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2025-08-25
07899258696966Stitch Cerclage - Suture TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2025-08-25
07899258696973Stitch Cerclage - Suture TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2025-08-25
07899258696980Stitch Cerclage - Suture TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2025-08-25
07899258696997Stitch Cerclage - Suture TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2025-08-25
07899258697000Stitch Cerclage - Suture TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2025-08-25
07899258697017Stitch Cerclage - Suture TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2025-08-25
07899258697024Stitch Cerclage - Suture TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2025-08-25
07899258697031Stitch Cerclage - Suture TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2025-08-25
00888867504561Arthrex®ARTHREX, INC.JDQ2025-06-17
00888867504585Arthrex®ARTHREX, INC.JDQ2025-06-17
00888867516717Arthrex®ARTHREX, INC.JDQ2025-05-16
00888867516724Arthrex®ARTHREX, INC.JDQ2025-05-16
00888867516748Arthrex®ARTHREX, INC.JDQ2025-05-16
07899258636658Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2025-04-25
07899258654560Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2025-04-25
07899258654706Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2025-04-25
10841291105794Sternal Cable SystemA & E MEDICAL CORPORATIONJDQ2025-04-21
10841291105824Sternal Cable SystemA & E MEDICAL CORPORATIONJDQ2025-04-21
10841291105831Sternal Cable SystemA & E MEDICAL CORPORATIONJDQ2025-04-21
10841291105855Sternal Cable SystemA & E MEDICAL CORPORATIONJDQ2025-04-21
10841291105862Sternal Cable SystemA & E MEDICAL CORPORATIONJDQ2025-04-21
10841291105893Sternal Cable SystemA & E MEDICAL CORPORATIONJDQ2025-04-21
10841291105909Sternal Cable SystemA & E MEDICAL CORPORATIONJDQ2025-04-21
10841291105916Sternal Cable SystemA & E MEDICAL CORPORATIONJDQ2025-04-21
10841291105923Sternal Cable SystemA & E MEDICAL CORPORATIONJDQ2025-04-21
10841291105930Sternal Cable SystemA & E MEDICAL CORPORATIONJDQ2025-04-21
10841291105947Sternal Cable SystemA & E MEDICAL CORPORATIONJDQ2025-04-21