FDA.reportPublic FDA data

Screwdriver HexaDrive

Primary DI
05712149027408
Brand
Screwdriver HexaDrive
Company
Oticon Medical AB
Model
265497
Catalog number
265497
Device description
Screwdriver HexaDrive. Consists of blade (DM DI 05712149027415) and handle (DM DI 05712149017422).
Published
2024-06-14
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
LRCInstrument, Ent Manual Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05712149027415Direct MarkingGS10
05712149027408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05712149027415057121490274155712149027415
05712149027408057121490274085712149027408

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
888-277-8014info@oticonmedical.com

Regulatory Flags#

DUNS number
554563994
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
05712149026562Ponto2276862276862022-09-17
05712149026579Ponto2276872276872022-09-17
05712149026586Ponto2276882276882022-09-17
05712149026593Ponto2276892276892022-09-17
05712149026609Ponto2276902276902022-09-17
05712149026616Ponto2276912276912022-09-17
05712149026623Ponto2276922276922022-09-17
05712149026630Ponto2276932276932022-09-17
05712149026722Ponto2277022277022022-09-17
05712149026739Ponto2277032277032022-09-17
05712149026746Ponto2277042277042022-09-17
05712149026753Ponto2277052277052022-09-17
05712149026760Ponto2277062277062022-09-17
05712149026777Ponto2277072277072022-09-17
05712149026784Ponto2277082277082022-09-17
05712149026791Ponto2277092277092022-09-17
05712149027743Ponto Instant2846482846482026-05-21
05712149027453Ponto2676342676342023-08-21
05712149027460Ponto2676352676352023-08-21
05712149027477Ponto2676362676362023-08-21

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Primary DI, Brand, Company table
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