ANTOLI-CANDELA "SHEA'S" KNIFE 10 DEGREE BLADE ANGLE 2.67 MM BLADE LEN

GUDID 00821925013407

Gyrus Acmi, Inc.

Surgical irrigation/aspiration handpiece, reusable Surgical irrigation/aspiration handpiece, reusable Surgical irrigation/aspiration handpiece, reusable Surgical irrigation/aspiration handpiece, reusable Surgical irrigation/aspiration handpiece, reusable Surgical irrigation/aspiration handpiece, reusable Surgical irrigation/aspiration handpiece, reusable Surgical irrigation/aspiration handpiece, reusable Surgical irrigation/aspiration handpiece, reusable Surgical irrigation/aspiration handpiece, reusable Surgical irrigation/aspiration handpiece, reusable Surgical irrigation/aspiration handpiece, reusable Surgical irrigation/aspiration handpiece, reusable Surgical irrigation/aspiration handpiece, reusable Surgical irrigation/aspiration handpiece, reusable Surgical irrigation/aspiration handpiece, reusable Surgical irrigation/aspiration handpiece, reusable Surgical irrigation/aspiration handpiece, reusable Surgical irrigation/aspiration handpiece, reusable Surgical irrigation/aspiration handpiece, reusable
Primary Device ID00821925013407
NIH Device Record Keyc5d9cdeb-2e91-4c71-88e8-e718ddf271be
Commercial Distribution StatusIn Commercial Distribution
Brand NameANTOLI-CANDELA "SHEA'S" KNIFE 10 DEGREE BLADE ANGLE 2.67 MM BLADE LEN
Version Model Number130161
Company DUNS007198742
Company NameGyrus Acmi, 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100821925013407 [Primary]

FDA Product Code

JZFTUBE, EAR SUCTION

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00821925013407]

Moist Heat or Steam Sterilization


[00821925013407]

Moist Heat or Steam Sterilization


[00821925013407]

Moist Heat or Steam Sterilization


[00821925013407]

Moist Heat or Steam Sterilization


[00821925013407]

Moist Heat or Steam Sterilization


[00821925013407]

Moist Heat or Steam Sterilization


[00821925013407]

Moist Heat or Steam Sterilization


[00821925013407]

Moist Heat or Steam Sterilization


[00821925013407]

Moist Heat or Steam Sterilization


[00821925013407]

Moist Heat or Steam Sterilization


[00821925013407]

Moist Heat or Steam Sterilization


[00821925013407]

Moist Heat or Steam Sterilization


[00821925013407]

Moist Heat or Steam Sterilization


[00821925013407]

Moist Heat or Steam Sterilization


[00821925013407]

Moist Heat or Steam Sterilization


[00821925013407]

Moist Heat or Steam Sterilization


[00821925013407]

Moist Heat or Steam Sterilization


[00821925013407]

Moist Heat or Steam Sterilization


[00821925013407]

Moist Heat or Steam Sterilization


[00821925013407]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-08-21
Device Publish Date2018-09-07