FDA.reportPublic FDA data

"SI Guidewire 9"""

Primary DI
00850040139587
Brand
"SI Guidewire 9"""
Company
Surgentec, LLC
Model
SR16-5001
Catalog number
SI-P-GP
Published
2024-08-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OURSacroiliac Joint Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OURSacroiliac Joint FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850040139587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850040139587008500401395878500401395870850040139587

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
004095409
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810131884055TiLink-L Rescue Drill GuideSR21-27002026-09-25
00810131884062TiLink-L Rescue DilatorSR21-67012026-09-25
00810131884079TiLink-L Rescue Impact CapSR21-67022026-09-25
00810131884086TiLink-L Rescue screw Drill bit – 10.5mmSR21-67032026-09-25
00810131884857TiLink-L Sterilization Tray – Double StackSR21-70202026-09-25
00810131884864TiLink-L Rescue CaddySR21-70212026-09-25
00810131882983BMAN BCOR Bone Marrow Aspirate KitAAN-09-BCORES2026-08-19
00810131884697BMAN BCOR Bone Marrow Aspirate Kit (with Clip)AAN-09-BCORE2026-08-19
00810131885045ION Non CervicalSR17-10002026-07-28
00810131881795ION Disposable Instrument KitTI-K-10002026-03-09
00810131881801ION 55 Facet Implant - SterileTI-K-552026-03-09
00810131881818ION 60 Facet Implant - SterileTI-K-602026-03-09
00810131881825ION 65 Facet Implant - SterileTI-K-652026-03-09
00810131882433ION-C Navigation LocatorSR12-25122026-07-06
00810131882440Ion Navigation Drill Bit - 5.0mmSR12-65102026-07-06
00810131882457Ion Navigation Drill Bit - 5.5mmSR12-65112026-07-06
00810131882464Ion Navigation Drill Bit - 4.5mmSR12-65092026-07-06
00810131882532TiLink-L Navigation Drill Bit - 8mmSR21-63052026-07-06
00810131882556TiLink-L Navigation Drill GuideSR21-63012026-07-06
00810131882563TiLink-L Navigation Inserter Hexalobe DriverSR21-63042026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B387T5II51300SiJoin T5 TitaniumVGI MEDICAL, LLCOUR2026-10-09
B387T5II51310SiJoin T5 TitaniumVGI MEDICAL, LLCOUR2026-10-09
00810131884055TiLink-L Rescue Drill GuideSurgentec, LLCOUR2026-09-25
00810131884062TiLink-L Rescue DilatorSurgentec, LLCOUR2026-09-25
00810131884079TiLink-L Rescue Impact CapSurgentec, LLCOUR2026-09-25
00810131884086TiLink-L Rescue screw Drill bit – 10.5mmSurgentec, LLCOUR2026-09-25
00810131884857TiLink-L Sterilization Tray – Double StackSurgentec, LLCOUR2026-09-25
00810131884864TiLink-L Rescue CaddySurgentec, LLCOUR2026-09-25
M719GSIX1210TiLockGenesys Orthopedics Systems LLCOUR2026-08-18
M719G120050SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120060SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120070SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120080SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120090SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120100SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120110SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120120SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120130SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120000SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719G120010SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719G120020SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719G120030SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719G120040SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719GSIX1260SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719GL201TL0SIros-XGenesys Orthopedics Systems LLCOUR2026-07-23
00889929072745NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCOUR2026-07-17
18257200140084Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200140091Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143368Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143375Firebird SI FusionOrthofix US LLCOUR2026-07-17