FDA.report

Apex

Primary DI
05391529588656
Brand
Apex
Company
ORTHOXEL DESIGNATED ACTIVITY COMPANY
Model
INS-1151
Catalog number
INS-1151
Device description
Flexible Hex Driver Ball Tip (5mm/8mm)
Published
2022-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HXXScrewdriver

Product Code Classifications

CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05391529588656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05391529588656053915295886565391529588656

GMDN Terms

TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Ambient Storage and Handling

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
646-661-3167customercare@orthoxel.com

Regulatory Flags

DUNS number
985596830
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DIBrandModelCatalogPublished
05391529588786ApexINS-1197INS-11972023-07-11
05391529588793ApexINS-1198INS-11982023-07-11
05391543064273ApexINS-1191INS-11912023-07-11
05391529587970ApexF05-100460F05-1004602023-07-10
05391529587987ApexF05-110240F05-1102402023-07-10
05391529587994ApexF05-110260F05-1102602023-07-10
05391529588007ApexF05-110280F05-1102802023-07-10
05391529588014ApexF05-110300F05-1103002023-07-10
05391529588021ApexF05-110320F05-1103202023-07-10
05391529588038ApexF05-110340F05-1103402023-07-10
05391529588045ApexF05-110360F05-1103602023-07-10
05391529588052ApexF05-110380F05-1103802023-07-10
05391529588069ApexF05-110400F05-1104002023-07-10
05391529588076ApexF05-110420F05-1104202023-07-10
05391529588083ApexF05-110440F05-1104402023-07-10
05391529588090ApexF05-110460F05-1104602023-07-10
05391529588106ApexF05-115240F05-1152402023-07-10
05391529588113ApexF05-115260F05-1152602023-07-10
05391529588120ApexF05-115280F05-1152802023-07-10
05391529588137ApexF05-115300F05-1153002023-07-10

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