FDA.reportPublic FDA data

Accu-Joint

Primary DI
00850044114641
Brand
Accu-Joint
Company
Accufix Surgical, Inc.
Model
AF100AJKW-D1.4
Catalog number
AJKW-D1.4
Device description
K-Wire Dispenser 1.4mm - 10mmD x 120mmL 304SS
Published
2022-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00850044114641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850044114641008500441146418500441146410850044114641

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. 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
Lot or batch
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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