FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867317949
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-18700-45
Catalog number
AR-18700-45
Device description
Pointed Reduction Forceps
Published
2019-12-13
Public version status
Update
Distribution status
Not 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
00888867317949PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867317949008888673179498888673179490888867317949

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic tissue manipulation forceps, reusableA rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. 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
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
00888867304598Arthrex®AR-7285AR-72852026-07-08
00888867304604Arthrex®AR-7286AR-72862026-07-08
00888867304789Arthrex®AR-7285-1AR-7285-12026-07-08
00888867304796Arthrex®AR-7286-1AR-7286-12026-07-08
00888867023987Arthrex®AR-1934BFT-2AR-1934BFT-22019-03-09
00888867097216Arthrex®AR-1938PHSAR-1938PHS2017-05-11
00888867157767Arthrex®AR-1588TN-2AR-1588TN-22017-08-15
00888867178649Arthrex®AR-8827L-32SAR-8827L-32S2017-04-07
00888867178694Arthrex®AR-8827L-42SAR-8827L-42S2017-04-07
00888867178731Arthrex®AR-8827L-50SAR-8827L-50S2017-04-07
00888867178748Arthrex®AR-8827L-52SAR-8827L-52S2017-04-07
00888867178755Arthrex®AR-8827L-54SAR-8827L-54S2017-05-11
00888867178762Arthrex®AR-8827L-56SAR-8827L-56S2017-05-11
00888867178779Arthrex®AR-8827L-58SAR-8827L-58S2017-05-11
00888867179455Arthrex®AR-8835-65SAR-8835-65S2017-04-07
00888867179462Arthrex®AR-8835-70SAR-8835-70S2017-04-07
00888867179479Arthrex®AR-8835-75SAR-8835-75S2017-04-07
00888867179486Arthrex®AR-8835-80SAR-8835-80S2017-04-07
00888867196537Arthrex®AR-8943C-07SAR-8943C-07S2017-05-11
00888867196582Arthrex®AR-8943C-12SAR-8943C-12S2017-05-11

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10705034647463N/AMedos International SàrlLXH2026-07-09
B382SD49400B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
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B382SD49420B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500010Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500020Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500030Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500040Surgical DirectSurgical Direct, Inc.LXH2026-07-09
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