FDA.reportPublic FDA data

No Brand

Primary DI
00885556716939
Brand
No Brand
Company
Smith & Nephew, Inc.
Model
E0015917-1
Catalog number
E0015917-1
Device description
LOCKING T-HANDLE
Published
2018-03-20
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
JDGProsthesis, hip, femoral component, cemented, metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDGProsthesis, Hip, Femoral Component, Cemented, MetalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123598000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123598000SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATIONSmith & Nephew, Inc.2013-06-28JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556716939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556716939008855567169398855567169390885556716939

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable 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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556925379CORIOGRAPHROB20032ROB200322026-07-08
00885556925386CORIOGRAPHROB20031ROB200312026-07-08
00885556904879EVOS70887105708871052026-06-25
00885556904923EVOS70897130708971302026-06-25
00885556906163EVOS70879090708790902026-06-25
00885556906170EVOS70879095708790952026-06-25
00885556906187EVOS70879100708791002026-06-25
00885556906194EVOS70879105708791052026-06-25
00885556906200EVOS70879110708791102026-06-25
00885556906217EVOS70879115708791152026-06-25
00885556906224EVOS70879120708791202026-06-25
00885556906231EVOS70879125708791252026-06-25
00885556906248EVOS70879130708791302026-06-25
00885556906255EVOS70879135708791352026-06-25
00885556906262EVOS70879140708791402026-06-25
00885556906279EVOS70879145708791452026-06-25
00885556906286EVOS70879150708791502026-06-25
00885556906293EVOS70879155708791552026-06-25
00885556906309EVOS70879160708791602026-06-25
00885556906316EVOS70879165708791652026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327383386ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383430ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383454ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383461ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383485ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383515ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383522ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383553ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383591ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383614ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383621ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383676ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383706ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383713ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383737ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383744ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383751ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383805ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383812ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383836ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383843ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383904ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383911ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327123852V40Howmedica Osteonics Corp.JDG2018-06-13
07613327123739EXETERHowmedica Osteonics Corp.JDG2018-05-03
07613327123746EXETERHowmedica Osteonics Corp.JDG2018-05-03
07613327123753EXETERHowmedica Osteonics Corp.JDG2018-05-03
07613327123777EXETERHowmedica Osteonics Corp.JDG2018-05-03
07613327123791EXETERHowmedica Osteonics Corp.JDG2018-05-03
07613327123845EXETERHowmedica Osteonics Corp.JDG2018-05-03