Calcar Planer

GUDID 00854515008774

Unique Surgical

Burring power tool attachment
Primary Device ID00854515008774
NIH Device Record Key9cb18ece-3189-432a-878b-f16006f7e2e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameCalcar Planer
Version Model NumberDiamond Tooth, Chip Relief Slots, Ø41mm
Company DUNS079820535
Company NameUnique Surgical
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone818-813-8527
Emailinfo@UniqueSurgical.com
Phone818-813-8527
Emailinfo@UniqueSurgical.com
Phone818-813-8527
Emailinfo@UniqueSurgical.com
Phone818-813-8527
Emailinfo@UniqueSurgical.com
Phone818-813-8527
Emailinfo@UniqueSurgical.com
Phone818-813-8527
Emailinfo@UniqueSurgical.com
Phone818-813-8527
Emailinfo@UniqueSurgical.com
Phone818-813-8527
Emailinfo@UniqueSurgical.com
Phone818-813-8527
Emailinfo@UniqueSurgical.com
Phone818-813-8527
Emailinfo@UniqueSurgical.com
Phone818-813-8527
Emailinfo@UniqueSurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100854515008774 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00854515008774]

Moist Heat or Steam Sterilization


[00854515008774]

Moist Heat or Steam Sterilization


[00854515008774]

Moist Heat or Steam Sterilization


[00854515008774]

Moist Heat or Steam Sterilization


[00854515008774]

Moist Heat or Steam Sterilization


[00854515008774]

Moist Heat or Steam Sterilization


[00854515008774]

Moist Heat or Steam Sterilization


[00854515008774]

Moist Heat or Steam Sterilization


[00854515008774]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-15
Device Publish Date2025-08-07

On-Brand Devices [Calcar Planer]

00854515008828Diamond Tooth, Ø38mm
00854515008774Diamond Tooth, Chip Relief Slots, Ø41mm

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