FDA.reportPublic FDA data

Arthrex®

Primary DI
10888867020457
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-1644
Catalog number
AR-1644
Device description
TRIMANO BEACH CHAIR KIT
Published
2018-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BWNTable and attachments, operating-room
FWZOperating Room Accessories Table Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWNTable And Attachments, Operating-RoomGeneral, Plastic Surgery1
FWZOperating Room Accessories Table TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888867020457PackageGS16In Commercial Distribution
00888867020450PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088886702045710888867020457
00888867020450008888670204508888670204500888867020450

GMDN Terms#

Term, Definition table
TermDefinition
Arm procedure positioner, reusableA preformed device designed to support and stabilize a patient's arm in a desired position during a medical procedure [e.g., orthopaedic surgery, anaesthesia administration, blood donation, intravenous (IV) infusion, physical therapy massage]. Also known as an arm posturing device or armboard, it is typically constructed as an elongated, curved, cushioned surface, and is typically attached or fixed onto a side rail, operation/examination table, blood donor couch, or a chair, and has adjustable height, tilt, rotation, and lock positioning capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00888867340183Arthrex®AR-D8400EXAR-D8400EX2019-10-06
00888867504288Arthrex®AR-9953AR-05AR-9953AR-052026-05-21
00888867504295Arthrex®AR-9953AR-03AR-9953AR-032026-05-21
00888867504318Arthrex®AR-9953AR-07AR-9953AR-072026-05-21
00888867504356Arthrex®AR-9953AR-09AR-9953AR-092026-05-21
00888867504363Arthrex®AR-9953AR-11AR-9953AR-112026-05-21
00888867504387Arthrex®AR-9953AR-13AR-9953AR-132026-05-21
00888867504394Arthrex®AR-9953AL-13AR-9953AL-132026-05-21
00888867504400Arthrex®AR-9953AR-15AR-9953AR-152026-05-21
00888867504417Arthrex®AR-9953AL-15AR-9953AL-152026-05-21
00888867504424Arthrex®AR-9953AR-03SAR-9953AR-03S2026-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00696588008370MorphBoard®Innovative Medical Products, IncFWZ2026-05-19
00696588008325De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2026-04-07
00696588008264De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2026-04-02
00696588008271De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2026-04-02
00696588008288De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2026-04-02
00696588008295De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2026-04-02
00696588008301De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2026-04-02
00696588008318De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2026-04-02
07640152574245FISSOBaitella AGFWZ2026-04-01
07640152574252FISSOBaitella AGFWZ2026-04-01
07640152574269FISSOBaitella AGFWZ2026-04-01
07640152574276FISSOBaitella AGFWZ2026-04-01
07640152574283FISSOBaitella AGFWZ2026-04-01
10653405986379CONMEDConmed CorporationFWZ2026-01-17
00696588008233De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-11-21
00198506086175ELMED INCORPORATEDELMED INCORPORATEDBWN2025-10-20
07640152573989FISSOBaitella AGFWZ2025-10-13
00724995245009NASTERIS CORPORATIONBWN2025-05-05
10192253053777DevonCardinal Health 200, LLCFWZ2025-03-21
00733657288131ATEC KIT 4 STRAPSALIMED, INC.FWZ2024-08-02
00724995220228NASTERIS CORPORATIONBWN2024-01-31
16945416406002NoneMEIXIN MEDICAL SUZHOU CO., LTD.BWN2023-09-30
16945416406019NoneMEIXIN MEDICAL SUZHOU CO., LTD.BWN2023-09-30
16945416407009NoneMEIXIN MEDICAL SUZHOU CO., LTD.BWN2023-09-30
16945416407016NoneMEIXIN MEDICAL SUZHOU CO., LTD.BWN2023-09-30
16945416407023NoneMEIXIN MEDICAL SUZHOU CO., LTD.BWN2023-09-30
16945416407030NoneMEIXIN MEDICAL SUZHOU CO., LTD.BWN2023-09-30
08056646508570Transparent drape 40x50 cm with adhesive tape for physiodispensers or for controOMNIA SRLFWZ2023-06-28
08056646508594Sheaths 120x7 cm with fixing elasticsOMNIA SRLFWZ2023-06-28
08056646508617Sheaths 240x7 cm cm with fixing elasticsOMNIA SRLFWZ2023-06-28