FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867101548
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-3370-0005
Catalog number
AR-3370-0005
Device description
OUTFLOW STOPCOCK FOR OUTFLOW SHEATH
Published
2018-06-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00888867101548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867101548008888671015488888671015480888867101548

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope sheath, reusableA component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. 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
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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