FDA.reportPublic FDA data

3/4 inch Cobb

Primary DI
00858406007716
Brand
3/4 inch Cobb
Company
Surgentec, LLC
Model
SR10-5010
Published
2024-12-18
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
FMFSyringe, Piston
HTRRasp

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
HTRRaspGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200431000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K2004310003D GraftRasp SystemSurgentec2020-05-18FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858406007716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858406007716008584060077168584060077160858406007716

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manual, single-useA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a single-use 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
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
00810131882617TiLink-L Navigation Impact CapSR21-63032026-07-06
00810131882761Facet Sterile Implant - 55FI-S-552026-07-06
00810131882808Facet Sterile Instrument Kit - CervicalFIC-10002026-07-06
00810131883270ION-C Navigation Drill Guide - AdjustableSR12-27002026-07-06
00810131883669Ion Navigation Inserter AOSR12-65012026-07-06
00810131884772ION-C Final KitTI-C-10002026-07-06
00810131884871ION-C Navigation Reusable TraySR25-70052026-07-06
00810131884895ION-C ReusableSR25-10002026-07-06
00810131884970ION-C Navigation Reusable Tray AssemblySR25-10022026-07-06
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

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