Handle with AO connection system

Primary DI
08437019739324
Brand
Handle with AO connection system
Company
ABANZA TECNOMED SL.
Model
21
Device description
Accessory handle used to insert instruments with AO connection.
Published
2023-06-01
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
GDZHandle, Scalpel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDZHandle, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28437019739328PackageGS11In Commercial Distribution
08437019739324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2843701973932828437019739328
08437019739324084370197393248437019739324

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(866) 550-7070customerservice@abanzamed.com

Regulatory Flags#

DUNS number
465714287
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
08437019739539Awl 9mm & 10mm212023-06-01
08437019739966WasherCap™ Surgical Instrument Set212023-06-01
08437019739744QuadLock™ Fixation System 9mmNA2026-01-14
08437019739751QuadLock™ Fixation System 10mmNA2026-01-14
08437019739768QuadLock™ Fixation System 11mmNA2026-01-14
08437019739430WasherCap™ Countersink 11 mm212026-03-30
08437019739447WasherCap™ Inserter 11mm212026-03-30
08437019739454WasherCap™ Countersink Positioner 11mm212026-03-30
08437019739461Inserter Coupling Screw 11mm212026-03-30
28437019739748QuadLock™ Fixation System 9mmNA2026-01-14
28437019739755QuadLock™ Fixation System 10mmNA2026-01-14
28437019739762QuadLock™ Fixation System 11mmNA2026-01-14
08437019739867WasherCap™ Fixation System 11mm212025-03-10
28437019739861WasherCap™ Fixation System 11mm212025-03-10
08437019739898WasherCap Mini Fixation system 3.5mm452025-02-25
08437019739904WasherCap Mini Fixation system 4.5mm452025-02-25
28437019739892WasherCap Mini Fixation system 3.5mm452025-02-25
28437019739908WasherCap Mini Fixation system 4.5mm452025-02-25
08437019739485WasherCap™ Inserter 7mm & 8mm212023-06-01
08437019739508WasherCap™ Inserter 9mm & 10mm212023-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860010523926APT NeedleRafael Medical Devices, LLCGDZ2026-10-01
00860010523933APT NeedleRafael Medical Devices, LLCGDZ2026-10-01
00724995267742Snowden-PencerSTERIS Deutschland GmbHGDZ2026-09-25
D955BLAHST1Paul BandittTerlain Enterprises, Inc.GDZ2026-09-25
00724995267728Snowden-PencerSTERIS Deutschland GmbHGDZ2026-09-24
00190776429072MillenniumAvalign Technologies, Inc.GDZ2026-09-04
00724995314682V. MuellerSteris CorporationGDZ2026-08-21
00724995314699V. MuellerSteris CorporationGDZ2026-08-21
00724995314705V. MuellerSteris CorporationGDZ2026-08-21
00724995314712V. MuellerSteris CorporationGDZ2026-08-21
00724995314729V. MuellerSteris CorporationGDZ2026-08-21
00724995317362V. MuellerSteris CorporationGDZ2026-08-21
00724995317379V. MuellerSteris CorporationGDZ2026-08-21
00724995320492V. MuellerSteris CorporationGDZ2026-08-21
00724995320508V. MuellerSteris CorporationGDZ2026-08-21
00724995320515V. MuellerSteris CorporationGDZ2026-08-21
00724995320522V. MuellerSteris CorporationGDZ2026-08-21
00724995320539V. MuellerSteris CorporationGDZ2026-08-21
00724995343446V. MuellerSteris CorporationGDZ2026-08-21
04054462913466evonosevonos GmbH & Co. KGGDZ2026-08-19
04054462913473evonosevonos GmbH & Co. KGGDZ2026-08-19
04054462913480evonosevonos GmbH & Co. KGGDZ2026-08-19
04054462913527evonosevonos GmbH & Co. KGGDZ2026-08-19
00190776422837MillenniumAvalign Technologies, Inc.GDZ2026-08-03
07613327651188VersiQuadSTRYKER CORPORATIONGDZ2026-07-22
00190776396800MillenniumAvalign Technologies, Inc.GDZ2026-07-14
00850083275563Intrace USAPILOTIS TECH LLCGDZ2026-07-03
00810055255689Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255696Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255702Surgical DesignSurgical Design, Inc.GDZ2026-06-26