FDA.reportPublic FDA data

Guide Pin - Bevel

Primary DI
00810131880910
Brand
Guide Pin - Bevel
Company
Surgentec, LLC
Model
SR99-5006
Published
2024-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810131880910PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810131880910008101318809108101318809100810131880910

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a K-Wire, it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
004095409
Device count
1
Premarket exempt
true
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
00810131881061 BMAC Bevel Needle SR07-1500AAN-11-BMACS2025-01-03
00810131880941 BMAN Solid Diamond Needle SR07-1100AAN-09-BMANS2024-12-31
00810131880958 BMAN Solid Diamond Needle Kit SR07-1101AAN-09-BMAN2024-12-31
00810131880965BMAN Solid Diamond Needle - Two Pack SR07-1102AAN-09-2BMANS2024-12-31
00810131880972BMAN Solid Diamond Needle Kit - Two Pack SR07-1103AAN-09-2BMAN2024-12-31
00810131881009 BMAC Diamond Needle SR07-1300AAN-09-BMACS2024-12-31
00850040139587"SI Guidewire 9"""SR16-5001SI-P-GP2024-08-16
00810131880583 Mallet - Large - Large HeadSR99-60002024-12-10
00810131880590 Mallet - Large - Small HeadSR99-60012024-12-10
00810131880606"1/4"" Square Drill Chuck"SR99-60022024-12-10
00810131880729 Bone Chisel SR99-60032024-12-10
00858406007181OsteoFlo Synthetic NanoPutty Syringe- 1ccONP-S-012020-11-19
00858406007198OsteoFlo Synthetic NanoPutty Syringe- 2.5ccONP-S-022020-11-19
00858406007204OsteoFlo Synthetic NanoPutty Syringe- 510ccONP-S-102020-11-19
00858406007211OsteoFlo Synthetic NanoPutty Syringe- 5ccONP-S-052020-11-19
00858406007228OsteoFlo Synthetic NanoPutty Cartridge- 5ccONP-T-5002020-11-18
00858406007235OsteoFlo Synthetic NanoPutty Cartridge- 10ccONP-T-10002020-11-19
00081013188039 ION AO Coupling Cannulated Handle SR12-50062026-03-09
00810131880330"T-Handle 3/16"" Connection"SR11-50022026-03-09
00810131881252 6.5/7.0 Drill Bit SR12-64422026-03-09

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