FDA.reportPublic FDA data

Reprocessed Large Tear Rasp, 12.7mm x 7mm

Primary DI
B3905100371161
Brand
Reprocessed Large Tear Rasp, 12.7mm x 7mm
Company
SURETEK MEDICAL
Model
5100-37-116
Published
2024-02-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GACRasp, Surgical, General & Plastic Surgery

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B3905100371161PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manual, reusableA 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 reusable device.

Regulatory Flags#

DUNS number
785616934
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B390197230FLA1Reprocessed 4mm EndoScrub Sheath, 45 deg, K Storz197230FLA2026-04-30
B39019120501Reprocessed 4mm EndoScrub Sheath, 0 deg19-120502024-06-19
B390197230BVA1Reprocessed 4mm EndoScrub Sheath, 30 deg197230BVA2022-12-26
B3901912050T1Reprocessed 4mm EndoScrub Sheath, 0 deg, w/Tubing19-12050T2023-12-27
B39019120271Reprocessed 2.7mm EndoScrub Sheath, 30 deg19-120272021-06-16
B3901912101Reprocessed 4mm EndoScrub Sheath, 30 deg1912102021-06-16
B3901912131Reprocessed 4mm EndoScrub Sheath, 45 deg1912132021-06-16
B3901912201Reprocessed 4mm EndoScrub Sheath, 70 deg1912202021-06-16
B3901912000T1Reprocessed 4mm EndoScrub Sheath, 0 deg, w/Tubing19-12000T2021-06-15
B3901912001Reprocessed 4mm EndoScrub Sheath, 0 deg1912002021-06-15
B390191200T1Reprocessed 4mm EndoScrub Sheath, 0 deg, w/Tubing191200T2021-06-15
B39019120101Reprocessed 4mm EndoScrub Sheath, 30 deg19-120102021-06-15
B39019120131Reprocessed 4mm EndoScrub Sheath, 45 deg, K Storz19-120132021-06-15
B39019120201Reprocessed 4mm EndoScrub Sheath, 70 deg19-120202021-06-15
B3901912000Reprocessed Endoscrub Sheath, 4mm, 0 deg19-120002021-06-14
B39016005391Reprocessed Shaver Blade Straight 3.5mm Double Serrated16005392025-12-09
B39016005741Reprocessed Shaver Blade Curved, 60 Deg, Double Serrated16005742025-12-09
B3901884002HRT1Reprocessed 4.0mm Serrated Blade, Rotatable, with Tubing18-84002HRT2025-12-09
B39062901120331Reprocessed 3mm Straight Shaver Blade6290-112-0332025-12-09
B3906290112040121Reprocessed 4mm Angled 12 Degree Shaver Blade6290-112-040-122025-12-09

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Primary DI, Brand, Company table
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05055445973025SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
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05055445973049SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
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