FDA.reportPublic FDA data

SYNFIX Evolution

Primary DI
10705034814193
Brand
SYNFIX Evolution
Company
Synthes GmbH
Model
03.835.050
Catalog number
03835050
Device description
SYNFIX® EVOLUTION IMPLANT PACKING STATION
Published
2016-06-30
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
LRPTRAY, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819658172Direct MarkingGS10
10705034814193PrimaryGS10
H981038350500SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819658172076118196581727611819658172
1070503481419310705034814193

GMDN Terms#

Term, Definition table
TermDefinition
Bone graft packing blockA device designed to tightly compact (pack) an implant with a bone graft material (e.g., autologous, allogeneic, xenogeneic, or of synthetic origin) prior to the implantation of the implant. It is typically a small, box-shaped device consisting of two parts, a frame to hold the implant to be filled and a fitted lid that stabilizes the implant while it is being filled. The packing of the implant is done manually, typically with an impactor. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
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
10886982030054LCP02.108.412021084122015-09-14
10886982033079VA-LCP02.112.049021120492015-09-14
10886982042590LCP02.124.213021242132015-09-14
10886982055552NA02.221.002S02221002S2015-09-14
10886982055569NA02.221.003S02221003S2015-09-14
10886982055583NA02.221.004S02221004S2015-09-14
10886982076748NA03.221.015032210152016-12-31
10886982076762NA03.221.016032210162016-12-31
10886982076779NA03.221.017032210172016-12-31
10886982120960NA04.221.002S04221002S2015-09-14
10886982120977NA04.221.003S04221003S2015-09-14
10886982120991NA04.221.004S04221004S2015-09-14
10886982182494NA298.800.01S29880001S2015-09-14
10886982182500NA298.801.01S29880101S2015-09-14
10886982198112NA391.1033911032016-12-31
10886982198129NA391.1043911042016-12-31
10886982198136NA391.1053911052016-12-31
10886982198143NA391.1063911062016-12-31
10886982198150NA391.1073911072016-12-31
10886982198167NA391.1083911082016-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091278ELMED INCORPORATEDELMED INCORPORATEDLRP2026-06-09
04052536163434neon3Ulrich GmbH & Co. KGLRP2026-06-09
04052536164585neon3Ulrich GmbH & Co. KGLRP2026-06-09
04052536164592neon3Ulrich GmbH & Co. KGLRP2026-06-09
04052536164608neon3Ulrich GmbH & Co. KGLRP2026-06-09
04052536177516neon3Ulrich GmbH & Co. KGLRP2026-06-09
04052536221202uCentumUlrich GmbH & Co. KGLRP2026-06-09
04052536221219uCentumUlrich GmbH & Co. KGLRP2026-06-09
04052536221233uCentumUlrich GmbH & Co. KGLRP2026-06-09
04052536162116neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536162130neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536162147neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536162154neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536162215neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536176724neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536176748neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536176755neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536176762neon3Ulrich GmbH & Co. KGLRP2026-06-08
10198956433755CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956461109CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956476950CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956479999CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956485112CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956487475CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956490109CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956490635CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956494817CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956501362CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956505841CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956506381CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08