FDA.reportPublic FDA data

Apex

Primary DI
05391529588700
Brand
Apex
Company
ORTHOXEL DESIGNATED ACTIVITY COMPANY
Model
INS-1156
Catalog number
INS-1156
Device description
Flexible IM Reamer Shaft 650mm
Published
2022-10-04
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
05391529588700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391529588700053915295887005391529588700

GMDN Terms#

Term, Definition table
TermDefinition
Medullary canal orthopaedic reamer shaftA flexible cylindrical device intended to accept an orthopaedic reamer head on its distal end and used during a procedure to open and enlarge a medullary canal (e.g., in the femur), for the insertion of devices during prosthesis implantation or for fracture fixation. It is designed to be mounted onto an appropriate surgical tool for manual or powered rotation and is made of flexible materials (e.g., carbon fibre); it has a hollow centre so it can be fed over a guide, and devices to assist the procedure (e.g., drill guiding pin, manual driver) may be provided with the device. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00ambient storage and handling

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
646-661-3167customercare@orthoxel.com

Regulatory Flags#

DUNS number
985596830
Device count
1
DM exempt
true
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
05391529588502ApexE04-020E04-0202022-08-17
05391529582128ApexE02-000E02-0002022-08-10
05391529582135ApexE02-005E02-0052022-08-10
05391529582142ApexE02-010E02-0102022-08-10
05391529582159ApexE02-015E02-0152022-08-10
05391529582166ApexE02-020E02-0202022-08-10
05391529582173ApexLE02-000LE02-0002022-08-10
05391529588465ApexE04-000E04-0002022-02-23
05391529588472ApexE04-005E04-0052022-02-23
05391529588489ApexE04-010E04-0102022-02-23
05391529588496ApexE04-015E04-0152022-02-23
05391529588519ApexLE04-000LE04-0002022-02-23
05391529585099ApexE03-000E03-0002021-02-05
05391529585105ApexE03-005E03-0052021-02-05
05391529585112ApexE03-010E03-0102021-02-05
05391529585129ApexE03-015E03-0152021-02-05
05391529585136ApexLE03-000LE03-0002021-02-05
05391529580773ApexE01-0052019-10-01
05391529580780ApexE01-0102019-10-01
05391529580797ApexE01-0152019-10-01

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Primary DI, Brand, Company table
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