FDA.reportPublic FDA data

BIRMINGHAM HIP RESURFACING (BHR)

Primary DI
03596010533500
Brand
BIRMINGHAM HIP RESURFACING (BHR)
Company
Smith & Nephew, Inc.
Model
90127561
Catalog number
90127561
Device description
BHR GUIDE ROD
Published
2015-05-06
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
NXTProsthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXTProsthesis, Hip, Semi-Constrained, Metal/Metal, ResurfacingUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P040033000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P040033000BIRMINGHAM HIP RESURFACING (BHR) SYSTEMSmith & Nephew, Inc.2006-05-09NXT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010533500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010533500035960105335003596010533500

GMDN Terms#

Term, Definition table
TermDefinition
Bone nail guidewire, reusableA long, thin, metal rod designed to guide intramedullary canal devices for performing the implantation of an intramedullary nail to treat damaged bone. The rod is usually manually inserted into the canal to typically guide a surgical instrument (e.g., a reamer) and the implantable nail. This device is made of metal [e.g., high-grade stainless steel, titanium (Ti)] and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). It may be used in femoral, tibial, humeral or supracondylar intramedullary canals. 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
00885554009101NA720770572077052015-08-30
00885556925690NAROB30080ROB300802026-06-04
03596010589101JOURNEY71422274714222742015-08-30
03596010589132JOURNEY71422277714222772015-08-30
03596010000675OXINIUM71343603713436032015-08-30
03596010474148OXINIUM71342800713428002015-08-30
03596010474162OXINIUM71342804713428042015-08-30
03596010474179OXINIUM71342808713428082015-08-30
03596010474209OXINIUM71343200713432002015-08-30
03596010474216OXINIUM71343203713432032015-08-30
03596010474223OXINIUM71343204713432042015-08-30
03596010474230OXINIUM71343208713432082015-08-30
03596010477279OXINIUM71343600713436002015-08-30
03596010477286OXINIUM71343604713436042015-08-30
03596010477293OXINIUM71343608713436082015-08-30
03596010488862OXINIUM71342200713422002015-08-30
03596010544193JOURNEY71461012714610122015-08-30
03596010544209JOURNEY71461013714610132015-08-30
03596010544216JOURNEY71461014714610142015-08-30
03596010544223JOURNEY71461015714610152015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03596010533722BIRMINGHAM HIPSmith & Nephew, Inc.NXT2017-11-16
03596010504630BIRMINGHAM HIPSmith & Nephew, Inc.NXT2017-11-15
03596010504609BIRMINGHAMHIPRESURFACING(BHR)Smith & Nephew, Inc.NXT2017-11-13
03596010504616BIRMINGHAM HIPSmith & Nephew, Inc.NXT2017-11-13
03596010503428BIRMINGHAM HIPTM RESURFACINGSmith & Nephew, Inc.NXT2015-11-25
03596010503435BIRMINGHAM HIPTM RESURFACINGSmith & Nephew, Inc.NXT2015-11-25
03596010503442BIRMINGHAM HIPTM RESURFACINGSmith & Nephew, Inc.NXT2015-11-25
03596010503459BIRMINGHAM HIPTM RESURFACINGSmith & Nephew, Inc.NXT2015-11-25
03596010503480BIRMINGHAM HIPTM RESURFACINGSmith & Nephew, Inc.NXT2015-11-25
03596010503497BIRMINGHAM HIPTM RESURFACINGSmith & Nephew, Inc.NXT2015-11-25
03596010503503BIRMINGHAM HIPTM RESURFACINGSmith & Nephew, Inc.NXT2015-11-25
03596010503510BIRMINGHAM HIPTM RESURFACINGSmith & Nephew, Inc.NXT2015-11-25
03596010503527BIRMINGHAM HIPTM RESURFACINGSmith & Nephew, Inc.NXT2015-11-25
03596010503541BIRMINGHAM HIPTM RESURFACINGSmith & Nephew, Inc.NXT2015-11-25
03596010012302MATRIXSmith & Nephew, Inc.NXT2015-10-05
03596010581716NASmith & Nephew, Inc.NXT2015-09-28
03596010591555NASmith & Nephew, Inc.NXT2015-09-28
03596010533746BIRMINGHAM HIPTM RESURFACINGSmith & Nephew, Inc.NXT2015-09-28
03596010533753BIRMINGHAM HIPTM RESURFACINGSmith & Nephew, Inc.NXT2015-09-28
03596010533760BIRMINGHAM HIPTM RESURFACINGSmith & Nephew, Inc.NXT2015-09-28
03596010533777BIRMINGHAM HIPTM RESURFACINGSmith & Nephew, Inc.NXT2015-09-28
03596010577825BIRMINGHAM HIP RESURFACING (BHR)Smith & Nephew, Inc.NXT2015-05-07
03596010533647BIRMINGHAM HIP RESURFACING (BHR)Smith & Nephew, Inc.NXT2015-05-07
03596010533678BIRMINGHAM HIP RESURFACING (BHR)Smith & Nephew, Inc.NXT2015-05-07
03596010502551BIRMINGHAM HIP RESURFACING (BHR)Smith & Nephew, Inc.NXT2015-05-06
03596010502612BIRMINGHAM HIP RESURFACING (BHR)Smith & Nephew, Inc.NXT2015-05-06
03596010502629BIRMINGHAM HIP RESURFACING (BHR)Smith & Nephew, Inc.NXT2015-05-06
03596010502643BIRMINGHAM HIP RESURFACING (BHR)Smith & Nephew, Inc.NXT2015-05-06
03596010502674BIRMINGHAM HIP RESURFACING (BHR)Smith & Nephew, Inc.NXT2015-05-06
03596010533265BIRMINGHAM HIP RESURFACING (BHR)Smith & Nephew, Inc.NXT2015-05-06