OPEN-END WRENCH

Primary DI
08435389800200
Brand
OPEN-END WRENCH
Company
BIOTECHNOLOGY INSTITUTE SL
Model
LLAV
Published
2022-11-23
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
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08435389800200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435389800200084353898002008435389800200

GMDN Terms#

Term, Definition table
TermDefinition
Dental torque wrenchA hand-held dental tool intended for the manual application of rotation to tighten/loosen/remove a device [e.g., dental implant, spatial register (localizer/tracker/calibrator)] fitted into or close to the oral cavity, and/or to a surgical instrument, in association with a dental surgical procedure [e.g., dental guided surgery registration]. It may have a built-in ratchet function, with forward and reverse direction, and a calibrated scale to which a recommended torque can be set; it is not a screwdriver. It is typically made of metallic or polymer materials and may have a standard socket connection to accommodate different tool bits/adaptors. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
461665312
Device count
1
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
08435389828150SAMPLE PREPARATION KITKSAP2026-05-27
08435389830160SHORT POSITIONER FOR UNIVERSAL PLUS PLATFORM (2 UNITS)CPUPC2026-05-27
08435389830177UNIVERSAL PLUS PLATFORM POSITIONER (2 UNITS)CPUP2026-05-27
08435389830207STOP & GUIDE® BOXCCG2026-05-27
08435389830436EXTRA SHORT DRILL; Ø3.5 MMF35XS2026-05-27
08435389830443SURGICAL GUIDE TEMPORARY BALL ATTACHMENT; MULTI-IM; Ø4,1 mmTBA412026-05-27
08435389830542FLATTENING FRONT CUTTING DRILL; Ø3.1FCFA312026-05-27
08435389830559FLATTENING FRONT CUTTING SHORT DRILL; Ø3.1FCFA31C2026-05-27
08435389830764MULTI-IM® HEALING CAP, TINY® & UNIVERSAL PLATFORM L:3 mmTPMIEU12026-05-27
08435389830962DRILL HOLDER FOR EXTRA SHORT DRILLSFFXS2026-05-27
08435389831266FLATTENING FRONT CUTTING DRILL, Ø4.1 INTERNA 3.0FCFA412026-05-27
08435389830825INTERNA 3.0 IMPLANT EXTENSION, 24 MMEAI3242026-03-31
08435389830832INTERNA 3.0 IMPLANT EXTENSION, 29 MMEAI3292026-03-31
08435389830849IMPLANT EXTENSION; INTERNA NARROW; 15MMINEAE152026-03-31
08435389830856INTERNA NARROW IMPLANT EXTENSION, 24 MMINEAE242026-03-31
08435389830863INTERNA NARROW IMPLANT EXTENSION, 29 MMINEAE292026-03-31
08435389830870INTERNA UNIVERSAL IMPLANT EXTENSOR, 15 MMINEAU152026-03-31
08435389830887INTERNA UNIVERSAL IMPLANT EXTENSOR , 24 MMINEAU242026-03-31
08435389830894INTERNA UNIVERSAL IMPLANT EXTENSOR, 29 MMINEAU292026-03-31
08435389828952EXTRACTOR FOR IMPLANTS 8EXIM82026-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06009544052876N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052883N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052890N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052906N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052920N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052937N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053071N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053088N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053095N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053101N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053118N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053125N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053132N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053149N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053156N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053163N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053248N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053293N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053347N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053354N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053361N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053415N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
07640149886726TRITRI Dental Implants Int. AGNDP2026-10-06
07640149886733TRITRI Dental Implants Int. AGNDP2026-10-06
07640149886757TRITRI Dental Implants Int. AGNDP2026-10-06
07640149886764TRITRI Dental Implants Int. AGNDP2026-10-06
06009544030287N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052401N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052418N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052425N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01