FDA.reportPublic FDA data

LARGE CANNULATED SCREWS

Primary DI
23596010121640
Brand
LARGE CANNULATED SCREWS
Company
Smith & Nephew, Inc.
Model
410236
Catalog number
410236
Device description
GUIDE PIN 230MM X 2.4MM
Published
2018-02-14
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
HRSPLATE, FIXATION, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123055000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123055000SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATIONSmith & Nephew, Inc.2013-01-25HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
23596010121640PackageGS16In Commercial Distribution
03596010121646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2359601012164023596010121640
03596010121646035960101216463596010121646

GMDN Terms#

Term, Definition table
TermDefinition
Bone nail guidewire, single-useA sterile, 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 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
false
Premarket exempt
false
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
00885556917435Real IntelligenceROB20040ROB200402024-04-10
00885556780886REAL INTELLIGENCEROB10013SROB10013S2022-01-13
00885556757321REAL INTELLIGENCEROB10013ROB100132020-07-02
03596010411020VERSABOND71271140712711402015-08-29
03596010494726VERSABOND71271340712713402015-08-29
03596010507372VERSABOND71271440712714402015-09-28
03596010033246NA1100281100282015-08-25
03596010038852NA1114301114302015-08-25
03596010038890NA1114341114342015-08-25
03596010041968BUCK1124281124282015-08-25
03596010384591MIXOR71270041712700412015-08-29
03596010384607MIXOR71270042712700422015-08-29
03596010384638MIXOR71270051712700512015-08-29
03596010384645MIXOR71270052712700522015-08-29
03596010437617RENOVATION71369045713690452015-08-30
03596010472175MIXOR71270060712700602015-08-29
03596010515018VORTEX71272001712720012015-08-29
03596010040077NA1118021118022015-08-25
00885556582213RALLY71271560712715602015-10-08
00885556582220RALLY71271570712715702015-10-08

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Primary DI, Brand, Company table
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