FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867504769
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-S1500-100
Catalog number
AR-S1500-100
Device description
Graft Gun
Published
2025-04-10
Public version status
New
Distribution status
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
00888867504769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867504769008888675047698888675047690888867504769

GMDN Terms#

Term, Definition table
TermDefinition
Bone graft delivery kitA collection of sterile devices intended to be used to prepare and/or deliver bone graft material during an orthopaedic surgical procedure. It typically includes aspirating/delivery/mixing syringe(s), an adaptor, and a needle/cannula. It allows for the aspiration and/or premixing of bone marrow, autologous blood, plasma, intravenous fluids (IVF), and bone void filler (e.g., allograft, autograft, synthetic bone graft material), and their delivery to the surgical site. 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
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
00888867020498Arthrex®AR-1648AR-16482018-08-03
00888867319882Arthrex®AR-8980BCTAR-8980BCT2021-06-24
00888867501317Arthrex®AR-1588SBR-RTTAR-1588SBR-RTT2025-06-23
00888867328693Arthrex®AR-8933VCL-10SAR-8933VCL-10S2024-08-05
00888867328709Arthrex®AR-8933VCL-12SAR-8933VCL-12S2024-08-05
00888867328716Arthrex®AR-8933VCL-14SAR-8933VCL-14S2024-08-05
00888867328723Arthrex®AR-8933VCL-16SAR-8933VCL-16S2024-08-05
00888867328730Arthrex®AR-8933VCL-18SAR-8933VCL-18S2024-08-05
00888867328747Arthrex®AR-8933VCL-20SAR-8933VCL-20S2024-08-05
00888867328754Arthrex®AR-8933VCL-22SAR-8933VCL-22S2024-08-05
00888867328761Arthrex®AR-8933VCL-24SAR-8933VCL-24S2024-08-05
00888867328778Arthrex®AR-8933VCL-26SAR-8933VCL-26S2024-08-05
00888867328785Arthrex®AR-8933VCL-28SAR-8933VCL-28S2024-08-05
00888867328792Arthrex®AR-8933VCL-30SAR-8933VCL-30S2024-08-05
00888867328808Arthrex®AR-8933VCL-32SAR-8933VCL-32S2024-08-05
00888867328815Arthrex®AR-8933VCL-34SAR-8933VCL-34S2024-08-05
00888867328822Arthrex®AR-8933VCL-36SAR-8933VCL-36S2024-08-05
00888867328839Arthrex®AR-8933VCL-38SAR-8933VCL-38S2024-08-05
00888867328846Arthrex®AR-8933VCL-40SAR-8933VCL-40S2024-08-05
00888867328860Arthrex®AR-8933HVCL-12SAR-8933HVCL-12S2024-08-05

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