FDA.report

AXIOM®

Primary DI
03663394482639
Brand
AXIOM®
Company
ETABLISSEMENTS ANTHOGYR
Model
OPR10
Device description
RING Ø10
Published
2023-12-27
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

Product Codes

CodeName
NDPAccessories, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03663394482639PrimaryGS10

GMDN Terms

TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Device Sizes

TypeValueUnit
Outer Diameter10Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
275978864
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
03663394482325HAND-PIECES / CONTRE-ANGLES47562025-12-17
03663394865371HAND-PIECES / CONTRE-ANGLES1600911-0012025-08-20
03663394170871IMPULSION87M2025-02-13
03663394482332Anthogyr OSTEOTOMEINMODOSTSV2024-07-17
03663394011099TORQCONTROL155012024-03-28
03663394173346Anthogyr UNIVERSAL SURGICAL INSTRUMENTINUSI2024-02-27
03663394482936AXIOM®INBW100XL2024-01-23
03663394484275AXIOM®OPFPSL20-ET2024-01-19
03663394484282AXIOM®OPGS20-ET2024-01-19
03663394484299AXIOM®OPGS36-ET2024-01-19
03663394484305AXIOM®OPGS42-ET2024-01-19
03663394484312AXIOM®OPGS50-ET2024-01-19
03663394484329AXIOM®OPFP20-ET2024-01-19
03663394165532AXIOM®OPFPSL20-52024-01-17
03663394165549AXIOM®OPFP202024-01-17
03663394479288AXIOM®INSETIGM2024-01-17
03663394479295AXIOM®OPFPD202024-01-17
03663394479301AXIOM®OPFPSL20-32024-01-17
03663394479318AXIOM®OPGS202024-01-17
03663394479325AXIOM®OPGS20-42024-01-17

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