FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867574489
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-8719TC
Catalog number
AR-8719TC
Device description
DynaNite Reduction Staple Inst Case
Published
2026-09-18
Public version status
New
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
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
00888867574489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867574489008888675744898888675744890888867574489

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. 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
true
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
00888867550292Arthrex®AR-6533S-STAR-6533S-ST2026-09-18
00888867550308Arthrex®AR-6533S-XLAR-6533S-XL2026-09-18
00888867550315Arthrex®AR-6534S-STAR-6534S-ST2026-09-18
00888867550322Arthrex®AR-6534S-XLAR-6534S-XL2026-09-18
00888867550339Arthrex®AR-6533S-STSAR-6533S-STS2026-09-18
00888867550346Arthrex®AR-6533S-XLSAR-6533S-XLS2026-09-18
00888867550353Arthrex®AR-6534S-STSAR-6534S-STS2026-09-18
00888867550360Arthrex®AR-6534S-XLSAR-6534S-XLS2026-09-18
00888867550377Arthrex®AR-6534S-14AR-6534S-142026-09-18
00888867550384Arthrex®AR-6534S-17AR-6534S-172026-09-18
00888867552692Arthrex®AR-6533S-XL-14AR-6533S-XL-142026-09-18
00888867552708Arthrex®AR-6533S-ST-14AR-6533S-ST-142026-09-18
00888867552715Arthrex®AR-6534S-ST-14AR-6534S-ST-142026-09-18
00888867552722Arthrex®AR-6533S-XLS-14AR-6533S-XLS-142026-09-18
00888867552739Arthrex®AR-6533S-STS-14AR-6533S-STS-142026-09-18
00888867552746Arthrex®AR-6534S-XL-14AR-6534S-XL-142026-09-18
00888867552753Arthrex®AR-6534S-STS-14AR-6534S-STS-142026-09-18
00888867552760Arthrex®AR-6534S-XLS-14AR-6534S-XLS-142026-09-18
00888867568044Arthrex®AR-9650RAO-05AR-9650RAO-052026-09-17
00888867568051Arthrex®AR-9650RAO-06AR-9650RAO-062026-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867574496Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574502Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574519Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574526Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574533Arthrex®ARTHREX, INC.MDM2026-09-18
10888277688896MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688902MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688919MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688926MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688933MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688940MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688957MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688964MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277689121MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10080196321384MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277688995MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689008MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689015MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689022MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689039MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689046MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689053MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689060MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689077MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689084MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689091MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689107MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10888277689114MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-14
10080196320417MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-09
10080196320424MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-09