FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867561793
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-9850DS
Catalog number
AR-9850DS
Device description
NanoScopic Release System, ECTR, 2.0
Published
2026-07-17
Public version status
New
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
GCJLaparoscope, general & plastic surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867561793PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867561793008888675617938888675617930888867561793

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. 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
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
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
00888867560475Arthrex®AR-9001A-5100AR-9001A-51002026-06-11
10888867501000Arthrex®76-1023076-102302026-03-13
10888867501017Arthrex®76-1023476-102342026-03-13
10888867501031Arthrex®76-1023576-102352026-03-13
10888867501048Arthrex®76-1023676-102362026-03-13
10888867544571Arthrex®71-0000471-000042026-03-13
00888867444966Arthrex®AR-9097-02AR-9097-022025-10-24
00888867444973Arthrex®AR-9097-03AR-9097-032025-10-24
00888867444980Arthrex®AR-9097-04AR-9097-042025-10-24
00888867457782Arthrex®AR-9099-02AR-9099-022025-11-28
00888867429871Arthrex®AR-2600FSB-3AR-2600FSB-32023-05-24
00888867429888Arthrex®AR-2600FSB-4AR-2600FSB-42023-05-24
00888867320734Arthrex®AR-8981BCTJ-CPAR-8981BCTJ-CP2021-06-24
10888867335179Arthrex®AR-18700-71AR-18700-712019-12-23
00888867038417Arthrex®AR-602-48AR-602-482018-06-02
00888867218208Arthrex®AR-1788PJ-CPAR-1788PJ-CP2019-11-15
00888867135697Arthrex®AR-9145-24NLAR-9145-24NL2017-02-15
00888867135765Arthrex®AR-9145-30NLAR-9145-30NL2017-02-15
00888867135840Arthrex®AR-9145-36NLAR-9145-36NL2017-02-15
00888867135918Arthrex®AR-9145-42NLAR-9145-42NL2017-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506092176ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-17
B382SD90781001000Surgical DirectSurgical Direct, Inc.GCJ2026-07-17
B382SD9918100Surgical DirectSurgical Direct, Inc.GCJ2026-07-17
B382SD1184590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD12711090Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD1271390Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD1271590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13018770Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13168350Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD23373490Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD770561050Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD775011530Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD775021630Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD77505650Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD7751586C0Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD7751587C0Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
00850045863012ArthroFree® 2 ReceiverLazurite Holdings LLCGCJ2026-07-10
00850045863029ArthroFree® 2 Wireless Camera HeadLazurite Holdings LLCGCJ2026-07-10
00850045863036ArthroFree® 2 Operating Room KitLazurite Holdings LLCGCJ2026-07-10
00850045863043ArthroFree® 2 Single Camera Head SetLazurite Holdings LLCGCJ2026-07-10
B382SD883110450Surgical DirectSurgical Direct, Inc.GCJ2026-07-10
B382SD88324450Surgical DirectSurgical Direct, Inc.GCJ2026-07-10
00190776421731MillenniumAvalign Technologies, Inc.GCJ2026-06-24
00190776421663MillenniumAvalign Technologies, Inc.GCJ2026-06-23
00190776421687MillenniumAvalign Technologies, Inc.GCJ2026-06-23
00198506091506ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-10
00198506044366ELMEDELMED INCORPORATEDGCJ2026-06-09
00812231033906PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033913PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033920PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08