Reamer

GUDID 00810111220095

cone reamer

TREACE MEDICAL CONCEPTS, INC.

Bone-resection orthopaedic reamer, reusable
Primary Device ID00810111220095
NIH Device Record Keybafa8cb6-0788-444d-8b76-d28ae0b14b4f
Commercial Distribution StatusIn Commercial Distribution
Brand NameReamer
Version Model Number1405-2464
Company DUNS054808082
Company NameTREACE MEDICAL CONCEPTS, 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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810111220095 [Primary]

FDA Product Code

HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


[00810111220095]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-20
Device Publish Date2022-09-12

On-Brand Devices [Reamer]

00853114006914cone reamer
00853114006907cup reamer
00853114006891cone reamer
00853114006884cup reamer
00853114006877cone reamer
00853114006860cup reamer
00853114006518MTP cone reamer 4 flutes
00853114006501MTP cup reamer 4 flutes
00853114006495MTP cone reamer 4 flutes
00853114006488MTP cup reamer 4 flutes
00853114006471MTP cone reamer 4 flutes
00853114006464MTP Cup reamer 4 flutes
00810111220095cone reamer
00810111220088Cup reamer
00810111220071Cone Reamer
00810111220064cup reamer
0081011122438316mm cup reamer
0081011122437623mm cone reamer
0081011122436923mm cup reamer
0081011122435221mm cone reamer
0081011122434521mm cup reamer
0081011122433818mm cone reamer
0081011122432118mm cup reamer

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.