FDA.reportPublic FDA data

LCP

Primary DI
10886982187437
Brand
LCP
Company
Synthes GmbH
Model
311.449
Catalog number
311449
Device description
PUSH-PULL REDUCTION DEVICE FOR 4.5MM LCP® PLATES
Published
2016-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTDFORCEPS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819915282Direct MarkingGS10
10886982187437PrimaryGS10
H6793114490SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819915282076118199152827611819915282
1088698218743710886982187437

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone-reduction toolA hand-held manual surgical instrument that is fed down the intramedullary canal of a long bone (e.g., the femur) to help reposition a fracture where the two sections are out of alignment to achieve reduction for consequent reaming and nailing of the bone. It is typically a short cylindrical device with a protruding pointed tip (straight or angled) and which is secured to the distal end of a long, thin, flexible rod/shaft having a handle at the proximal end. It is pressed down the intramedullary canal to the fracture site and the surgeon manipulates the alignment, reducing the bone fragments under image-intensifier control. It is made of high-grade stainless steel. This is a reusable 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982239297NA519.51519512017-02-20
10886982195937NA357.2223572222017-02-20
10886982238115NA511.9045119042016-12-31
10886982239358NA519.53519532016-12-31
10886982249043NA60.550.011605500112017-02-20
10886982249104NA60.550.016605500162017-02-20
10886982249135NA60.550.020605500202017-02-20
10886982249142NA60.550.021605500212017-02-20
10886982254917NA690.5946905942017-02-20
10886982362797NASD03.111.915SD031119152026-08-26
10886982362803NASD03.111.916SD031119162026-08-26
10886982362810NASD03.111.917SD031119172026-08-26
10886982362827NASD03.111.918SD031119182026-08-26
10886982362834NASD03.111.919SD031119192026-08-26
10886982362988NASD312.030SD3120302026-08-26
10886982362995NASD312.031SD3120312026-08-26
10886982363008NASD312.032SD3120322026-08-26
10886982363015NASD312.033SD3120332026-08-26
10887587078496NASD03.503.037SD035030372026-08-26
10887587078595NASD03.501.444SD035014442026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776424015MillenniumAvalign Technologies, Inc.HTD2026-08-27
00192896123632Adson Dressing ForcepsSONTEC INSTRUMENTS, INC.HTD2026-08-27
00190776419738MillenniumAvalign Technologies, Inc.HTD2026-08-25
00850088713596PRINCETONPrinceton Medical Group, Inc.HTD2026-08-25
00850088713619PRINCETONPrinceton Medical Group, Inc.HTD2026-08-25
04054462901821evonosevonos GmbH & Co. KGHTD2026-08-21
04054462901852evonosevonos GmbH & Co. KGHTD2026-08-21
04054462901869evonosevonos GmbH & Co. KGHTD2026-08-21
04054462901876evonosevonos GmbH & Co. KGHTD2026-08-21
04054462901883evonosevonos GmbH & Co. KGHTD2026-08-21
04054462901890evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903405evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903450evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903467evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903504evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903573evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903597evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903603evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903634evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903641evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903658evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903665evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903672evonosevonos GmbH & Co. KGHTD2026-08-21
04054462903740evonosevonos GmbH & Co. KGHTD2026-08-21
04054462904129evonosevonos GmbH & Co. KGHTD2026-08-21
04054462904143evonosevonos GmbH & Co. KGHTD2026-08-21
04054462904235evonosevonos GmbH & Co. KGHTD2026-08-21
04054462904273evonosevonos GmbH & Co. KGHTD2026-08-21
04054462904310evonosevonos GmbH & Co. KGHTD2026-08-21
04054462904358evonosevonos GmbH & Co. KGHTD2026-08-21