FDA.reportPublic FDA data

Reprocessed 4.0mm Cool Cut Double Cut Blade

Primary DI
B390AR8400DC1
Brand
Reprocessed 4.0mm Cool Cut Double Cut Blade
Company
SURETEK MEDICAL
Model
AR-8400DC
Published
2018-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NBHAccessories, Arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B390AR8400DC1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic shaver system blade, reprocessedA sterile, powered, rotational, cutting device designed for use in an arthroscopic shaver system handpiece for soft and bone tissue resection during arthroscopic surgery on a joint, e.g., a knee, shoulder, or ankle. It is locked into a handpiece, and typically consists of a small outer tube with a hub and a rotating inner tube with a connector. The inner and outer tubes are typically made of high-grade stainless steel; the hub and connector may be made of stainless steel or a polymer [e.g., polyphenylsulfone (PPSU)]. This is a previously used single-use device that has been processed for an additional single-use patient application.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
785616934
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B39019120501Reprocessed 4mm EndoScrub Sheath, 0 deg19-120502024-06-19
B390197230BVA1Reprocessed 4mm EndoScrub Sheath, 30 deg197230BVA2022-12-26
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
B3906290112040601Reprocessed 4mm Angled 60 Degree Shaver Blade6290-112-040-602025-12-09
B3901161701Reprocessed Mako Blade Standard, 2mm1161702025-09-18
B3901161711Reprocessed Mako Blade Narrow, 2mm1161712025-09-18
B39021081821Reprocessed Sagittal Saw Blade, 18.6 x 1.24 x 84.4mm2108-1822025-09-05
B3903105201Reprocessed 1.8mm Drill Bit, Quick Coupling, 125mm310.5202025-09-05
B390KM35251Reprocessed Small Bone Osc Sagittal Blade, Thin, 31 x 9 x 0.38mmKM3-5252025-09-05
B390311340681Reprocessed 4mm Round Fine Diamond Bur Long311340682025-07-23
B390030001131Reprocessed 2.3mm Lindemann Reamer03.000.1132025-07-18
B39016005401Reprocessed Shaver Blade Straight 4.0mm Double Serrated16005402025-06-20
B39062901120401Reprocessed 4mm Straight Shaver Blade6290-112-0402025-06-05
B39062902080251Reprocessed 2.5mm Straight Shaver Blade6290-208-0252025-06-05
B39072053121Reprocessed 3.5mm Incisor Blade72053122025-06-05
B39016005381Reprocessed Shaver Blade Straight 3.0mm Double Serrated16005382025-05-30

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Primary DI, Brand, Company table
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B382SD316590Surgical DirectSurgical Direct, Inc.NBH2026-02-26
B382SD316790Surgical DirectSurgical Direct, Inc.NBH2026-02-26
B382SD9156321000Surgical DirectSurgical Direct, Inc.NBH2026-02-26
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