FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867427105
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-S7715-066-260
Catalog number
AR-S7715-066-260
Device description
Rasp, 6.6 x 260mm
Published
2023-06-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTZINSTRUMENT, CUTTING, ORTHOPEDIC
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTZInstrument, Cutting, OrthopedicGeneral, Plastic Surgery1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867427105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867427105008888674271058888674271050888867427105

GMDN Terms#

Term, Definition table
TermDefinition
Manual surgical rotary handpiece, reusableA manually-powered, hand-held, surgical device intended to be used to provide rotary motion for an endpiece (not included) during a surgical procedure such as cutting, sculpting, trepanning, or drilling bone and driving Kirschner wires; it is not dedicated to a specific clinical procedure. It is available in two main designs: 1) a U-shaped drill brace powered by the surgeon who holds the top of the brace steady whilst rotating it with horizontal crankshaft-like movements; or 2) a drill powered by the rotation of a side-mounted handle, and which may be cannulated to allow for use of a guidewire. Both types may have a Jacobs chuck or collet to hold the drill bit. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)934-4404complaints@arthrex.com

Regulatory Flags#

DUNS number
131747628
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
00888867614956Arthrex®AR-S8457EXCAR-S8457EXC2026-05-25
00888867531949Arthrex®AR-8827H-22SAR-8827H-22S2026-03-16
00888867531970Arthrex®AR-8827H-28SAR-8827H-28S2026-03-16
00888867531987Arthrex®AR-8827H-30SAR-8827H-30S2026-03-16
00888867532014Arthrex®AR-8827H-36SAR-8827H-36S2026-03-16
00888867134874Arthrex®AR-9104-04AR-9104-042017-02-15
00888867336506Arthrex®AR-1593-4AR-1593-42019-12-13
00888867336520Arthrex®AR-1593DAR-1593D2019-12-13
00888867310209Arthrex®AR-4158TAR-4158T2019-11-15
00888867340183Arthrex®AR-D8400EXAR-D8400EX2019-10-06
00888867504288Arthrex®AR-9953AR-05AR-9953AR-052026-05-21
00888867504295Arthrex®AR-9953AR-03AR-9953AR-032026-05-21
00888867504318Arthrex®AR-9953AR-07AR-9953AR-072026-05-21
00888867504356Arthrex®AR-9953AR-09AR-9953AR-092026-05-21
00888867504363Arthrex®AR-9953AR-11AR-9953AR-112026-05-21
00888867504387Arthrex®AR-9953AR-13AR-9953AR-132026-05-21
00888867504394Arthrex®AR-9953AL-13AR-9953AL-132026-05-21
00888867504400Arthrex®AR-9953AR-15AR-9953AR-152026-05-21
00888867504417Arthrex®AR-9953AL-15AR-9953AL-152026-05-21
00888867504424Arthrex®AR-9953AR-03SAR-9953AR-03S2026-05-21

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