FDA.reportPublic FDA data

Trigen

Primary DI
00885556694039
Brand
Trigen
Company
Smith & Nephew, Inc.
Model
E0015509-1
Catalog number
E0015509-1
Device description
BONE HOOK
Published
2017-05-16
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
GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDGHook, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556694039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556694039008855566940398855566940390885556694039

GMDN Terms#

Term, Definition table
TermDefinition
Bone hookA hand-held, surgical instrument used for hooking around or into bone, typically to grasp, hold, and apply traction to the bone during a surgical intervention. It is a shaft-like instrument with a robust design and can have a singular hook or multiple hooks at the distal end and a handle of various designs at the proximal end. It is made of high-grade stainless steel. It is sometimes called a bone retractor. 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
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
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09348811019639INKAThe Trustee for KAISER FAMILY TRUSTGDG2025-11-21
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10381780503828Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2019-02-19
10381780503835Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2019-02-19
10649111028496Sklar®SKLAR CORPORATIONGDG2019-02-06
10649111029844Sklar®SKLAR CORPORATIONGDG2019-02-06
10381780449195Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-12-19
10649111021435Sklar®SKLAR CORPORATIONGDG2018-12-07
10649111021701Sklar®SKLAR CORPORATIONGDG2018-12-07
10649111023842Sklar®SKLAR CORPORATIONGDG2018-12-07
10649111050367Sklar®SKLAR CORPORATIONGDG2018-12-03
10649111044007Sklar®SKLAR CORPORATIONGDG2018-11-20
10649111020469Sklar®SKLAR CORPORATIONGDG2018-11-07
10649111020650Sklar®SKLAR CORPORATIONGDG2018-11-07
10649111020759Sklar®SKLAR CORPORATIONGDG2018-11-07
10381780495833Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-10-24
10381780498681Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-09-18
10381780498698Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-09-18
10381780498704Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-09-18
10381780490418Integra® MicroFrance®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-09-14
10381780218135Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-09-12
10381780229827Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-09-12
10381780506447Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-09-12