Modular Reamer Cutter Head SLN-T02-090

GUDID B058SLNT020901

Modular Reamer Cutter Head, 9mm

Orthopedic Designs North America, Inc.

Medullary canal orthopaedic reamer, rigid
Primary Device IDB058SLNT020901
NIH Device Record Keya904be0b-b374-4497-8c5a-e689ec311e8c
Commercial Distribution StatusIn Commercial Distribution
Brand NameModular Reamer Cutter Head
Version Model NumberSLNT02090
Catalog NumberSLN-T02-090
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 Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB058SLNT020901 [Primary]

FDA Product Code

HTOReamer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B058SLNT020901]

Moist Heat or Steam Sterilization

[B058SLNT020901]

Moist Heat or Steam Sterilization

[B058SLNT020901]

Moist Heat or Steam Sterilization

[B058SLNT020901]

Moist Heat or Steam Sterilization

[B058SLNT020901]

Moist Heat or Steam Sterilization

[B058SLNT020901]

Moist Heat or Steam Sterilization

[B058SLNT020901]

Moist Heat or Steam Sterilization

[B058SLNT020901]

Moist Heat or Steam Sterilization

[B058SLNT020901]

Moist Heat or Steam Sterilization

[B058SLNT020901]

Moist Heat or Steam Sterilization

[B058SLNT020901]

Moist Heat or Steam Sterilization

[B058SLNT020901]

Moist Heat or Steam Sterilization

[B058SLNT020901]

Moist Heat or Steam Sterilization

[B058SLNT020901]

Moist Heat or Steam Sterilization

[B058SLNT020901]

Moist Heat or Steam Sterilization

[B058SLNT020901]

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.