FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867212619
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-9300SR
Catalog number
AR-9300SR
Device description
SABRE, 3.0MM X 7CM
Published
2018-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFABLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFABlade, Saw, General & Plastic Surgery, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888867212616PackageGS15In Commercial Distribution
00888867212619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088886721261610888867212616
00888867212619008888672126198888672126190888867212619

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bur, reusableA rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a reusable device.

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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867007482Arthrex®AR-13100-05.0SAR-13100-05.0S2017-01-20
00888867007529Arthrex®AR-13100-09.0SAR-13100-09.0S2017-01-20
00888867007567Arthrex®AR-13100-11.0SAR-13100-11.0S2017-01-20
00888867007604Arthrex®AR-13100-15.0SAR-13100-15.0S2017-01-20
00888867007628Arthrex®AR-13100-17.5SAR-13100-17.5S2017-01-20
00888867008564Arthrex®AR-13200-03.0SAR-13200-03.0S2017-01-20
00888867204041Arthrex®AR-8952XLSAR-8952XLS2017-07-18
00888867210424Arthrex®AR-8933L-26SAR-8933L-26S2017-08-31
00888867210431Arthrex®AR-8933L-28SAR-8933L-28S2017-08-31
00888867210448Arthrex®AR-8933L-30SAR-8933L-30S2017-08-31
00888867210462Arthrex®AR-8933L-34SAR-8933L-34S2017-08-31
00888867210479Arthrex®AR-8933L-36SAR-8933L-36S2017-08-31
00888867210493Arthrex®AR-8933L-40SAR-8933L-40S2017-08-31
00888867251960Arthrex®AR-8958-01SAR-8958-01S2017-11-28
00888867266872Arthrex®AR-8952PPLAR-8952PPL2017-03-28
00888867266896Arthrex®AR-8952PSRAR-8952PSR2017-03-28
00888867266957Arthrex®AR-8952PPRAR-8952PPR2017-03-28
00888867371828Arthrex®AR-8924SAR-8924S2023-05-25
00888867251939Arthrex®AR-8958-02AR-8958-022017-02-15
00888867279285Arthrex®AR-7249-12-1AR-7249-12-12017-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800053401531SharkCutTechcord co.,LtdGFA2024-04-16
08800053401548SharkCutTechcord co.,LtdGFA2024-04-16
08800053401586SharkCutTechcord co.,LtdGFA2024-04-16
08800053401593SharkCutTechcord co.,LtdGFA2024-04-16
08800053401616SharkCutTechcord co.,LtdGFA2024-04-16
08800053401623SharkCutTechcord co.,LtdGFA2024-04-16
08800053401647SharkCutTechcord co.,LtdGFA2024-04-16
08800053401654SharkCutTechcord co.,LtdGFA2024-04-16
08800053401678SharkCutTechcord co.,LtdGFA2024-04-16
08800053401692SharkCutTechcord co.,LtdGFA2024-04-16
08800053401142SharkCutTechcord co.,LtdGFA2024-04-15
08800053401159SharkCutTechcord co.,LtdGFA2024-04-15
08800053401166SharkCutTechcord co.,LtdGFA2024-04-15
08800053401173SharkCutTechcord co.,LtdGFA2024-04-15
08800053401180SharkCutTechcord co.,LtdGFA2024-04-15
08800053401197SharkCutTechcord co.,LtdGFA2024-04-15
08800053401203SharkCutTechcord co.,LtdGFA2024-04-15
08800053401210SharkCutTechcord co.,LtdGFA2024-04-15
08800053401227SharkCutTechcord co.,LtdGFA2024-04-15
08800053401234SharkCutTechcord co.,LtdGFA2024-04-15
08800053401241SharkCutTechcord co.,LtdGFA2024-04-15
08800053401258SharkCutTechcord co.,LtdGFA2024-04-15
08800053401289SharkCutTechcord co.,LtdGFA2024-04-15
08800053401296SharkCutTechcord co.,LtdGFA2024-04-15
08800053401302SharkCutTechcord co.,LtdGFA2024-04-15
08800053401319SharkCutTechcord co.,LtdGFA2024-04-15
08800053401326SharkCutTechcord co.,LtdGFA2024-04-15
08800053401333SharkCutTechcord co.,LtdGFA2024-04-15
08800053401340SharkCutTechcord co.,LtdGFA2024-04-15
08800053401357SharkCutTechcord co.,LtdGFA2024-04-15