FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867007451
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-1309H
Catalog number
AR-1309H
Device description
HIP RASP, LONG
Published
2018-04-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
00888867007451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867007451008888670074518888670074510888867007451

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manualA 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.

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
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
00888867561687Arthrex®AR-2600FSF-1AR-2600FSF-12026-03-17
00888867561694Arthrex®AR-2600FSF-2AR-2600FSF-22026-03-17
00888867561700Arthrex®AR-2600FSF-3AR-2600FSF-32026-03-17
00888867463363Arthrex®AR-8974-02AR-8974-022026-03-16
00888867519459Arthrex®AR-8974FCAR-8974FC2026-03-16
00888867519473Arthrex®AR-8974FCLAR-8974FCL2026-03-16
00888867519503Arthrex®AR-8974TAR-8974T2026-03-16
00888867519510Arthrex®AR-8974TLAR-8974TL2026-03-16
00888867529038Arthrex®AR-8827H-10AR-8827H-102026-03-16
00888867529045Arthrex®AR-8827H-12AR-8827H-122026-03-16
00888867529052Arthrex®AR-8827H-14AR-8827H-142026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776417918MillenniumAvalign Technologies, Inc.NBH2026-03-23
00190776417949MillenniumAvalign Technologies, Inc.NBH2026-03-23
00190776418267MillenniumAvalign Technologies, Inc.NBH2026-03-23
B382SD18129DK0Surgical DirectSurgical Direct, Inc.NBH2026-03-09
B382SD316590Surgical DirectSurgical Direct, Inc.NBH2026-02-26
B382SD316790Surgical DirectSurgical Direct, Inc.NBH2026-02-26
B382SD9156321000Surgical DirectSurgical Direct, Inc.NBH2026-02-26
00190776416386MillenniumAvalign Technologies, Inc.NBH2026-02-16
04055207068243VERTEBRISRichard Wolf GmbHNBH2026-02-10
04055207069691NARichard Wolf GmbHNBH2026-02-10
04055207069707NARichard Wolf GmbHNBH2026-02-10
04055207069714NARichard Wolf GmbHNBH2026-02-10
04055207069721NARichard Wolf GmbHNBH2026-02-10
04055207069738NARichard Wolf GmbHNBH2026-02-10
04055207069745NARichard Wolf GmbHNBH2026-02-10
B382SD181290Surgical DirectSurgical Direct, Inc.NBH2026-02-06
10748426142719Arthrex®Microtek Medical LLCNBH2026-02-02
07630542726620SportMeds InstrumentsMedacta International SANBH2026-01-30
00888867516144Arthrex®ARTHREX, INC.NBH2026-01-28
00888867516168Arthrex®ARTHREX, INC.NBH2026-01-28
07630542703683SportMeds InstrumentsMedacta International SANBH2026-01-21
00812231034170ZEOSSANTA BARBARA IMAGING SYSTEMS, INC.NBH2026-01-19
00812231034941ZEOSSANTA BARBARA IMAGING SYSTEMS, INC.NBH2026-01-19
00198506087622ELMED INCORPORATEDELMED INCORPORATEDNBH2026-01-16
04055207069790NARichard Wolf GmbHNBH2026-01-14
04055207069806NARichard Wolf GmbHNBH2026-01-14
04055207069813NARichard Wolf GmbHNBH2026-01-14
04055207069820NARichard Wolf GmbHNBH2026-01-14
04055207069837NARichard Wolf GmbHNBH2026-01-14
04055207069851NARichard Wolf GmbHNBH2026-01-14