FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867272446
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-5566-01
Catalog number
AR-5566-01
Device description
Arthrex VIP System, Instrument Set
Published
2017-08-17
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
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
00888867272446PrimaryGS10
M150AR5566010SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867272446008888672724468888672724460888867272446

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made orthopaedic/craniofacial surgical guideA custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is typically manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical 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
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
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
00888867384866Arthrex®AR-3200-1053AR-3200-10532021-09-24
00888867338050Arthrex®ABS-4085-TPABS-4085-TP2020-07-01
00888867339941Arthrex®AR-3200-1052AR-3200-10522019-08-08
00888867389526Arthrex®AR-9928P-CPAR-9928P-CP2024-05-29
00888867425736Arthrex®AR-9928BCK-DXAR-9928BCK-DX2023-05-22
00888867101968Arthrex®AR-3600DSAR-3600DS2017-02-15
00888867038936Arthrex®AR-6068-45RAR-6068-45R2018-09-15
00888867306004Arthrex®AR-9501FTKAR-9501FTK2021-06-30
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

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