FDA.reportPublic FDA data

Accu-Joint

Primary DI
00850061635365
Brand
Accu-Joint
Company
Accufix Surgical, Inc.
Model
ACFX2021-1-SUS
Catalog number
ACFX2021-1-SUS
Device description
Accu-Joint 1st MPJ Tray - SUS
Published
2024-11-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850061635365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850061635365008500616353658500616353650850061635365

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
045694474
Device count
1
Premarket exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850044114962Accu-JointAJMI-10-20-2AJMI-10-20-22024-11-11
00850044114979Accu-JointAJMT-10-2-TAJMT-10-2-T2024-11-11
00850044114986Accu-JointAJMS-16-2-SAJMS-16-2-S2024-11-11
00850044114993Accu-JointAJMS-14-2-SAJMS-14-2-S2024-11-11
00850061635006Accu-JointAJMS-12-2-SAJMS-12-2-S2024-11-11
00850061635013Accu-JointAJMS-18-2-SAJMS-18-2-S2024-11-11
00850061635020Accu-JointAJMT-18-2-TAJMT-18-2-T2024-11-11
00850061635037Accu-JointAJMI-18-20-2AJMI-18-20-22024-11-11
00850061635044Accu-JointAJMS-10-2-SAJMS-10-2-S2024-11-11
00850061635051Accu-JointACFX2023-1ACFX2023-12024-11-11
00850061635082Accu-JointAJMS-10-SAJMS-10-S2024-11-11
00850061635099Accu-JointAJMS-9-SAJMS-9-S2024-11-11
00850061635105Accu-JointAJMS-11-SAJMS-11-S2024-11-11
00850061635112Accu-JointAJPS-8-SAJPS-8-S2024-11-11
00850061635129Accu-JointAJPS-9-SAJPS-9-S2024-11-11
00850061635136Accu-JointAJPS-10-SAJPS-10-S2024-11-11
00850061635143Accu-JointAJPS-11-SAJPS-11-S2024-11-11
00850061635150Accu-JointAJPS-13-SAJPS-13-S2024-11-11
00850061635167Accu-JointAJPS-15-SAJPS-15-S2024-11-11
00850061635174Accu-JointAJPS-17-SAJPS-17-S2024-11-11

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