Glidesafe Handpiece P2VPHPD

GUDID 00841494105075

GLIDESAFE HP VARI-PAK 10MM,15MM&20MM-INT

Ellman International

Electrosurgical system
Primary Device ID00841494105075
NIH Device Record Keyfad3961e-ad01-4fa8-9ba6-0a319b06b4fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameGlidesafe Handpiece
Version Model NumberP2VPHPD
Catalog NumberP2VPHPD
Company DUNS079095245
Company NameEllman International
Device Count3
DM Exempttrue
Pre-market Exemptfalse
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
GS100841494105075 [Primary]
GS110841494105072 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-21

Devices Manufactured by Ellman International

00841494102371 - CORNEAL SHIELD2019-05-23 CORNEAL SHIELD L(BLUE), 4 SHIELD, 1 HDLE
00841494102388 - CORNEAL SHIELD2019-05-23 CORNEAL SHIELD M(GREEN),4 SHIELD,1 HDLE
00841494102395 - CORNEAL SHIELD2019-05-23 CORNEAL SHIELD S(RED),4 SHIELDS,1 HANDLE
00841494102401 - CORNEAL SHIELDS2019-05-23 CORNEAL SHIELDS ASSORTED PACKAGE(S, M, L)
00841494104801 - SUCTION HANDLE2019-05-23 SUCTION HANDLE(25PCS)FOR CORNEAL SHIELDS
00841494104818 - SUCTION HANDLE FOR CORNEAL SHIELDS2019-05-23 SUCTION HANDLE(2PCS) FOR CORNEAL SHIELDS
00841494101015 - 1/8" PIN ELECTRODE2019-02-07 1/8" PIN ELECTRODE - 25 PCS STERILE
00841494101305 - Needle Electrode2019-02-07 3/4" STRAIGHT NEEDLE STERILE, SINGLE-USE

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