FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867316218
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-18700-08
Catalog number
AR-18700-08
Device description
Drill Guide, 1.1 / 1.4mm
Published
2019-12-23
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
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867316218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867316218008888673162188888673162180888867316218

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. 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
true
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
00888867576032Arthrex®AR-3636-REMPAR-3636-REMP2026-10-20
00888867576056Arthrex®AR-3641SP-REMPAR-3641SP-REMP2026-10-20
00888867576070Arthrex®AR-6573-1AR-6573-12026-10-20
00888867576087Arthrex®AR-6573-2AR-6573-22026-10-20
00888867568280Arthrex®AR-3210-0050-SJAR-3210-0050-SJ2026-10-16
00888867568297Arthrex®AR-3210-0051-SJAR-3210-0051-SJ2026-10-16
00888867568303Arthrex®AR-3210-0059-PKAR-3210-0059-PK2026-10-16
00888867568310Arthrex®AR-3210-0063-PKAR-3210-0063-PK2026-10-16
00888867568457Arthrex®AR-8650DS-NAR-8650DS-N2026-10-16
00888867427143Arthrex®AR-S6524-025-230CAR-S6524-025-230C2023-06-05
00888867389533Arthrex®AR-9928BCK-MISAR-9928BCK-MIS2023-05-22
00888867276086Arthrex®AR-9437-16AR-9437-162022-07-15
00888867060401Arthrex®AR-9439-16AR-9439-162018-06-02
00888867060418Arthrex®AR-9439-18AR-9439-182018-06-02
00888867060425Arthrex®AR-9441-16AR-9441-162018-06-14
00888867060432Arthrex®AR-9441-18AR-9441-182018-06-02
00888867060449Arthrex®AR-9443-16AR-9443-162018-06-14
00888867060456Arthrex®AR-9443-18AR-9443-182018-06-14
00888867060463Arthrex®AR-9445-17AR-9445-172018-06-28
00888867060470Arthrex®AR-9445-19AR-9445-192018-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776436834MillenniumAvalign Technologies, Inc.MDM2026-10-22
07540277009663RMAC Surgical MarkerRMAC Surgical, IncMDM2026-10-21
00190776435080MillenniumAvalign Technologies, Inc.MDM2026-10-15
00840456225332JMUJMU DENTAL, INCMDM2026-10-13
00840456225349JMUJMU DENTAL, INCMDM2026-10-13
06955045515634hoboatJiangsu Hope Biomedical Science&Technology Co.,Ltd.MDM2026-10-13
06955045515689hoboatJiangsu Hope Biomedical Science&Technology Co.,Ltd.MDM2026-10-13
00190776434120MillenniumAvalign Technologies, Inc.MDM2026-10-09
00190776434229MillenniumAvalign Technologies, Inc.MDM2026-10-09
00190776433840MillenniumAvalign Technologies, Inc.MDM2026-10-08
00190776433857MillenniumAvalign Technologies, Inc.MDM2026-10-08
00190776433673MillenniumAvalign Technologies, Inc.MDM2026-10-07
00190776436162MillenniumAvalign Technologies, Inc.MDM2026-10-07
G141526051160Carnegie Surgical LLCCarnegie Surgical LLCMDM2026-10-07
00190776433536MillenniumAvalign Technologies, Inc.MDM2026-10-06
00190776434311MillenniumAvalign Technologies, Inc.MDM2026-10-06
00810220800584Adler Instrument CompanyAdler, Inc.MDM2026-09-30
00190776432775MillenniumAvalign Technologies, Inc.MDM2026-09-29
00888867618961Arthrex®ARTHREX, INC.MDM2026-09-28
00888867621237Arthrex®ARTHREX, INC.MDM2026-09-28
10888277689251MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689268MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689282MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689299MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689305MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689312MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689329MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689336MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689343MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689350MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28