Disposable Cranial Perforator 200-253 DGR -II

GUDID 00810607000057

Cranial Perforator

ACRA-CUT INC

Cranial trephine, single-use Cranial trephine, single-use
Primary Device ID00810607000057
NIH Device Record Keybe7fd91f-18db-4073-ab96-84f07eecb225
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Cranial Perforator
Version Model Number200-253 11/7 mm
Catalog Number200-253 DGR -II
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
GS100810607000057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HBFDrills, Burrs, Trephines & Accessories (Compound, Powered)

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00810607000057]

Radiation Sterilization


[00810607000057]

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 [Disposable Cranial Perforator]

00810607000125Cranial Perforator
00810607000118Cranial Perforator
00810607000101Cranial Perforator
00810607000095Cranial Perforator
00810607000088Cranial Perforator
00810607000071Cranial Perforator
00810607000064Cranial Perforator
00810607000057Cranial Perforator
00810607000040Cranial Perforator
00810607000033Cranial Perforator
00810607000026Cranial Perforator
00810607000019Cranial Perforator

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