FDA.reportPublic FDA data

NA

Primary DI
03596010552525
Brand
NA
Company
Smith & Nephew, Inc.
Model
74222300
Catalog number
74222300
Device description
BHR MODULAR SLEEVE +4MM 12/14
Published
2015-09-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWLProsthesis, hip, hemi-, femoral, metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010552525PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010552525035960105525253596010552525

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation sleeve, reusableA hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010479235ECHELON71342011713420112015-09-28
03596010479266ECHELON71342014713420142015-09-28
03596010479273ECHELON71342015713420152015-09-28
03596010479297ECHELON71342017713420172015-09-28
03596010479303ECHELON71342018713420182015-09-28
03596010479310ECHELON71342019713420192015-09-28
03596010479341ECHELON71343012713430122015-09-28
03596010459749SYNERGY71309109713091092015-08-30
03596010459756SYNERGY71309110713091102015-08-30
03596010459787SYNERGY71309113713091132015-08-30
03596010459794SYNERGY71309114713091142015-08-30
03596010459817SYNERGY71309116713091162015-08-30
03596010459831SYNERGY71309118713091182015-08-30
03596010479259ECHELON71342013713420132015-09-28
03596010479280ECHELON71342016713420162015-09-28
03596010479358ECHELON71343013713430132015-09-28
03596010479365ECHELON71343014713430142015-09-28
03596010479389ECHELON71343016713430162015-09-28
03596010479396ECHELON71343017713430172015-09-28
03596010479402ECHELON71343018713430182015-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613153071273RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071280RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071310RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071327RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071334RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071358RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071365RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071372RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071389RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071396RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071419RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071433RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071440RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071518RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071587RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071600RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071617RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071631RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071648RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153071655RestorationHowmedica Osteonics Corp.KWL2015-09-24
07613153072867TridentHowmedica Osteonics Corp.KWL2015-09-24
07613153072874TridentHowmedica Osteonics Corp.KWL2015-09-24
07613153072898TridentHowmedica Osteonics Corp.KWL2015-09-24
07613153072904TridentHowmedica Osteonics Corp.KWL2015-09-24
07613153072911TridentHowmedica Osteonics Corp.KWL2015-09-24
07613153072928TridentHowmedica Osteonics Corp.KWL2015-09-24
07613153072959TridentHowmedica Osteonics Corp.KWL2015-09-24
07613153072980TridentHowmedica Osteonics Corp.KWL2015-09-24
07613153072997TridentHowmedica Osteonics Corp.KWL2015-09-24
07613153073000TridentHowmedica Osteonics Corp.KWL2015-09-24