PicoDriver 023268

GUDID 10850012846434

PicoDriver Device

LSI Solutions, Inc.

Suturing unit, single-use
Primary Device ID10850012846434
NIH Device Record Key9a35dd86-4196-4f83-9e12-4b01466a1569
Commercial Distribution StatusIn Commercial Distribution
Brand NamePicoDriver
Version Model Number023268
Catalog Number023268
Company DUNS603420183
Company NameLSI Solutions, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850012846437 [Primary]
GS110850012846434 [Package]
Contains: 00850012846437
Package: Inner Pack [6 Units]
In Commercial Distribution

FDA Product Code

GDFGUIDE, NEEDLE, SURGICAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-28
Device Publish Date2025-07-19

Devices Manufactured by LSI Solutions, Inc.

10850012846434 - PicoDriver2025-07-28PicoDriver Device
10850012846434 - PicoDriver2025-07-28 PicoDriver Device
10850012846465 - RAPORT™ KIT2025-07-17 RAPORT™ KIT RP-75™
10850012846472 - RAPORT™ KIT2025-07-17 RAPORT™ KIT RP-100™
10850012846526 - RD® QUICK LOAD®2025-07-17 RD® QUICK LOAD® SUTURE, 2-0 MONOGLIDE® DUO
10850012846458 - JNW URTRAC2025-06-16 JNW URTRAC INSTRUMENT GUIDE
10850012846427 - COR-KNOT MICRO2025-05-12 COR-KNOT® MICRO Twin Pack
00850012846277 - multiSTATION™2025-05-05 multiSTATION™ ARTICULATING ADAPTER
00850012846383 - multiSTATION™2025-03-12 LITA RetroSterno™ Paddle

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