Cranial Blade Disposable low speed 800-140 Single

GUDID 00810607000408

Cranial Blade Disposable Low Speed 800-140 Single, Spiral Flute

ACRA-CUT INC

Cranial trephine, single-use Cranial trephine, single-use
Primary Device ID00810607000408
NIH Device Record Keya03af73e-f57f-469d-a913-ed56d4bee15f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCranial Blade Disposable low speed
Version Model Number800-140 Single
Catalog Number800-140 Single
Company DUNS612611459
Company NameACRA-CUT INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9782632210
Emailinfo@acracut.com
Phone9782632210
Emailinfo@acracut.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810607000408 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00810607000408]

Radiation Sterilization


[00810607000408]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-05-01

On-Brand Devices [Cranial Blade Disposable low speed]

00810607000415Cranial Blade Disposable Low Speed 800-140 Package of 5, Spiral Flute
00810607000408Cranial Blade Disposable Low Speed 800-140 Single, Spiral Flute
00810607000392Cranial Blade Disposable Low Speed 800-130 Package of 5, Straight Flute
00810607000385Cranial Blade Disposable Low Speed 800-130 Single, Straight Flute

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