FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867358089
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-15974NR
Catalog number
AR-15974NR
Device description
Mini FiberTape Retriever 3.4, 220mm NR
Published
2020-09-30
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
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867358089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867358089008888673580898888673580890888867358089

GMDN Terms#

Term, Definition table
TermDefinition
Suturing unit, reusableA non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft; it may in addition knot and/or cut the sutures as they are placed. 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
00888867007482Arthrex®AR-13100-05.0SAR-13100-05.0S2017-01-20
00888867007529Arthrex®AR-13100-09.0SAR-13100-09.0S2017-01-20
00888867007567Arthrex®AR-13100-11.0SAR-13100-11.0S2017-01-20
00888867007604Arthrex®AR-13100-15.0SAR-13100-15.0S2017-01-20
00888867007628Arthrex®AR-13100-17.5SAR-13100-17.5S2017-01-20
00888867008564Arthrex®AR-13200-03.0SAR-13200-03.0S2017-01-20
00888867204041Arthrex®AR-8952XLSAR-8952XLS2017-07-18
00888867210424Arthrex®AR-8933L-26SAR-8933L-26S2017-08-31
00888867210431Arthrex®AR-8933L-28SAR-8933L-28S2017-08-31
00888867210448Arthrex®AR-8933L-30SAR-8933L-30S2017-08-31
00888867210462Arthrex®AR-8933L-34SAR-8933L-34S2017-08-31
00888867210479Arthrex®AR-8933L-36SAR-8933L-36S2017-08-31
00888867210493Arthrex®AR-8933L-40SAR-8933L-40S2017-08-31
00888867251960Arthrex®AR-8958-01SAR-8958-01S2017-11-28
00888867266872Arthrex®AR-8952PPLAR-8952PPL2017-03-28
00888867266896Arthrex®AR-8952PSRAR-8952PSR2017-03-28
00888867266957Arthrex®AR-8952PPRAR-8952PPR2017-03-28
00888867371828Arthrex®AR-8924SAR-8924S2023-05-25
00888867251939Arthrex®AR-8958-02AR-8958-022017-02-15
00888867279285Arthrex®AR-7249-12-1AR-7249-12-12017-12-01

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