FDA.reportPublic FDA data

Arthrex®

Primary DI
10888867127200
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-8737-42
Catalog number
AR-8737-42
Device description
".045"" GUIDE WIRE TROCAR, THREADED"
Published
2021-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NBHAccessories, arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888867127200PrimaryGS10
00888867127203Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088886712720010888867127200
00888867127203008888671272038888671272030888867127203

GMDN Terms#

Term, Definition table
TermDefinition
Suture/needle passer, single-useA sterile, hand-held, manual surgical instrument designed for passing (driving) sutures and suture needles through tissues/prosthetic materials to facilitate suturing (it is not dedicated to ophthalmic applications). A passer, also known as a needle driver, is a long, thin, rod-like device that may be flexible or rigid in design and have hooks, catches, clasps, or forceps-like jaws at the distal end that grip/hold. The distal end will typically terminate as a button, rounded, or acorn tip, while the proximal end will have a handle or lever that is operated by the user. This is a single-use 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
6
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
00888867430662Arthrex®AR-S7110-020U-330WAR-S7110-020U-330W2023-09-15
00888867427310Arthrex®AR-S7111-025-330WAR-S7111-025-330W2023-06-05
00888867427327Arthrex®AR-S7111-035-330WAR-S7111-035-330W2023-06-05
00888867427334Arthrex®AR-S7115-025-260WAR-S7115-025-260W2023-06-05
00888867427341Arthrex®AR-S7116-020-260WAR-S7116-020-260W2023-06-05
00888867427358Arthrex®AR-S7116-025U-330WAR-S7116-025U-330W2023-06-05
00888867427365Arthrex®AR-S7121-020-330WAR-S7121-020-330W2023-06-05
00888867427372Arthrex®AR-S7115-025-330WAR-S7115-025-330W2023-06-05
00888867427389Arthrex®AR-S7116-025-330WAR-S7116-025-330W2023-06-05
00888867427396Arthrex®AR-S7116-025-260WAR-S7116-025-260W2023-06-05
00888867427495Arthrex®AR-S7120-025-330WAR-S7120-025-330W2023-06-05
00888867427518Arthrex®AR-S7110-025-330WAR-S7110-025-330W2023-06-05
00888867427532Arthrex®AR-S7110-040-330WAR-S7110-040-330W2023-06-05
00888867427549Arthrex®AR-S7110-025-260WAR-S7110-025-260W2023-06-05
00888867427556Arthrex®AR-S7110-035-260WAR-S7110-035-260W2023-06-05
00888867427563Arthrex®AR-S7110-040-260WAR-S7110-040-260W2023-06-05
00888867427570Arthrex®AR-S7110-030-330WAR-S7110-030-330W2023-06-05
00888867427891Arthrex®AR-S7116-040-260WAR-S7116-040-260W2023-06-05
00888867427907Arthrex®AR-S7116-035U-260WAR-S7116-035U-260W2023-06-05
00888867430686Arthrex®AR-S7110-025U-330WAR-S7110-025U-330W2023-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD319590Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD480084LH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD48008SLH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481014SLH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481022LH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481752CBDYN0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481752PT0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481755STR0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481756STR0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481760DYN0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD483003STR0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD487193000Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD487223000Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD5235320Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD142090Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD1814DK70Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD18252590Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD30609CH0Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD316390Surgical DirectSurgical Direct, Inc.NBH2026-07-31
00198506093258ELMED INCORPORATEDELMED INCORPORATEDNBH2026-07-28
00810143908534SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909449SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909456SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909463SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909470SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909487SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909494SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909500SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909531SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909555SURGIPROSSurgipros, LLCNBH2026-07-28