Modular Reamer Cutter Head SLN-T02-105

GUDID B058SLNT021051

Modular Reamer Cutter Head, 10.5mm

Orthopedic Designs North America, Inc.

Medullary canal orthopaedic reamer, rigid
Primary Device IDB058SLNT021051
NIH Device Record Key2e4f8b62-7963-4e5a-9142-3bb763dd4f23
Commercial Distribution StatusIn Commercial Distribution
Brand NameModular Reamer Cutter Head
Version Model NumberSLNT02105
Catalog NumberSLN-T02-105
Company DUNS945518848
Company NameOrthopedic Designs North America, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com

Device Dimensions

Outer Diameter10.5 Millimeter
Outer Diameter10.5 Millimeter
Outer Diameter10.5 Millimeter
Outer Diameter10.5 Millimeter
Outer Diameter10.5 Millimeter
Outer Diameter10.5 Millimeter
Outer Diameter10.5 Millimeter
Outer Diameter10.5 Millimeter
Outer Diameter10.5 Millimeter
Outer Diameter10.5 Millimeter
Outer Diameter10.5 Millimeter
Outer Diameter10.5 Millimeter
Outer Diameter10.5 Millimeter
Outer Diameter10.5 Millimeter
Outer Diameter10.5 Millimeter
Outer Diameter10.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB058SLNT021051 [Primary]

FDA Product Code

HTOReamer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B058SLNT021051]

Moist Heat or Steam Sterilization

[B058SLNT021051]

Moist Heat or Steam Sterilization

[B058SLNT021051]

Moist Heat or Steam Sterilization

[B058SLNT021051]

Moist Heat or Steam Sterilization

[B058SLNT021051]

Moist Heat or Steam Sterilization

[B058SLNT021051]

Moist Heat or Steam Sterilization

[B058SLNT021051]

Moist Heat or Steam Sterilization

[B058SLNT021051]

Moist Heat or Steam Sterilization

[B058SLNT021051]

Moist Heat or Steam Sterilization

[B058SLNT021051]

Moist Heat or Steam Sterilization

[B058SLNT021051]

Moist Heat or Steam Sterilization

[B058SLNT021051]

Moist Heat or Steam Sterilization

[B058SLNT021051]

Moist Heat or Steam Sterilization

[B058SLNT021051]

Moist Heat or Steam Sterilization

[B058SLNT021051]

Moist Heat or Steam Sterilization

[B058SLNT021051]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-05
Device Publish Date2023-06-27

On-Brand Devices [Modular Reamer Cutter Head]

B058SLNT021301Modular Reamer Cutter Head, 13mm
B058SLNT021251Modular Reamer Cutter Head, 12.5mm
B058SLNT021201Modular Reamer Cutter Head, 12mm
B058SLNT021151Modular Reamer Cutter Head, 11.5mm
B058SLNT021101Modular Reamer Cutter Head, 11mm
B058SLNT021051Modular Reamer Cutter Head, 10.5mm
B058SLNT021001Modular Reamer Cutter Head, 10mm
B058SLNT020951Modular Reamer Cutter Head, 9.5mm
B058SLNT020901Modular Reamer Cutter Head, 9mm
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.