RAM® DEVICE 021900

GUDID 10850200006671

RAM® SUTURING DEVICE 3.5mm

LSI Solutions, Inc.

Suturing unit, single-use
Primary Device ID10850200006671
NIH Device Record Key3dc10642-09be-44b1-a7c4-bcbc288ca94a
Commercial Distribution StatusIn Commercial Distribution
Brand NameRAM® DEVICE
Version Model Number021900
Catalog Number021900
Company DUNS603420183
Company NameLSI Solutions, Inc.
Device Count1
DM Exempttrue
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 Numbertrue
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
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
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
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com

Device Dimensions

Length8.5 Inch
Length8.5 Inch
Length8.5 Inch
Length8.5 Inch
Length8.5 Inch
Length8.5 Inch
Length8.5 Inch
Length8.5 Inch
Length8.5 Inch
Length8.5 Inch
Length8.5 Inch
Length8.5 Inch
Length8.5 Inch
Length8.5 Inch
Length8.5 Inch
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100850200006674 [Primary]
GS110850200006671 [Package]
Contains: 00850200006674
Package: Case [6 Units]
In Commercial Distribution
GS140850200006672 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWSINSTRUMENTS, SURGICAL, CARDIOVASCULAR

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-30
Device Publish Date2020-03-13

Devices Manufactured by LSI Solutions, Inc.

00850012846376 - multiSTATION™2024-11-25 10mm COUPLER
10850200006497 - SEW-EASY®2024-10-29 SEW-EASY® COMBO KIT, 5mm
10850200006503 - SEW-EASY®2024-10-29 SEW-EASY® COMBO KIT, 3.5mm
10850200006510 - SEW-EASY®2024-10-29 SEW-EASY® DEVICE KIT, 5mm
10850200006527 - SEW-EASY®2024-10-29 SEW-EASY® DEVICE KIT, 3.5mm
00850012846253 - multiSTATION™2024-10-07 DOC-X 15™ EXTENDER
00850012846352 - multiSTATION™2024-10-07 DOC-X 25™ EXTENDER
00850012846369 - multiSTATION™2024-10-07 DOC-X 45™ EXTENDER

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.