FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867271654
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-1938TC
Catalog number
AR-1938TC
Device description
SUTURE TENSIONER/CUTTER
Published
2018-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
10888867271651PackageGS15In Commercial Distribution
00888867271654PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088886727165110888867271651
00888867271654008888672716548888672716540888867271654

GMDN Terms#

Term, Definition table
TermDefinition
Suture knot pusher, single-useA hand-held manual surgical instrument that enables the user performing an internal suturing procedure (e.g., suturing a heart valve in the thoracic cavity) to advance suture knots created extracorporeally to the point of appropriate suture tension. It is a long, thin, rod-like device that has a guiding mechanism (e.g., an eyelet or groove) at its distal end, allowing it to be steered down one end of the suture as it pushes the knot with its blunted nose. Saline may be used to lubricate the suture and the knot pusher if necessary. This is a single-use device.

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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867543904Arthrex®AR-1101TH-13CT-SAR-1101TH-13CT-S2026-09-25
00888867543911Arthrex®AR-1101TH-8CT-SAR-1101TH-8CT-S2026-09-25
00888867543928Arthrex®AR-1101TH-13OT-SAR-1101TH-13OT-S2026-09-25
00888867543935Arthrex®AR-1101TH-8OT-SAR-1101TH-8OT-S2026-09-25
00888867460973Arthrex®AR-9001A-7140CSAR-9001A-7140CS2026-06-11
00888867291690Arthrex®AR-3350-4031AR-3350-40312018-12-13
00888867291751Arthrex®AR-3355-4031AR-3355-40312018-12-13
00888867161085Arthrex®AR-3350-4071AR-3350-40712018-12-13
00888867161207Arthrex®AR-3355-4071AR-3355-40712018-12-13
00888867504059Arthrex®AR-9650CAR-9650C2026-09-21
00888867504066Arthrex®AR-9650C-01AR-9650C-012026-09-21
00888867504073Arthrex®AR-9650C-02AR-9650C-022026-09-21
00888867570764Arthrex®AR-9650SFL-10256AR-9650SFL-102562026-09-21
00888867570771Arthrex®AR-9650SFL-11250AR-9650SFL-112502026-09-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888277688988MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689190MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689206MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689213MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689220MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689237MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689244MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
20888277688978MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10080196320899MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321407MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321414MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321438MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321452MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321469MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321476MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321483MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321490MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10888277689183MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321445MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-24
00190776431587MillenniumAvalign Technologies, Inc.MDM2026-09-22
00850088713886PRINCETONPrinceton Medical Group, Inc.MDM2026-09-22
00850088713893PRINCETONPrinceton Medical Group, Inc.MDM2026-09-22
00888867574489Arthrex®ARTHREX, INC.MDM2026-09-18
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