SMARTSTITCH M-CONNECTOR OM-8078

GUDID 00817470007442

SMARTSTITCH SUTURE CART. - ASSOR

Smith & Nephew, Inc.

Arthroscopic suturing unit
Primary Device ID00817470007442
NIH Device Record Key926ef8f8-6587-4557-8ced-6fbf0b3c1833
Commercial Distribution StatusIn Commercial Distribution
Brand NameSMARTSTITCH M-CONNECTOR
Version Model NumberOM-8078
Catalog NumberOM-8078
Company DUNS109903521
Company NameSmith & Nephew, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817470007442 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GATSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-31
Device Publish Date2015-10-08

On-Brand Devices [SMARTSTITCH M-CONNECTOR]

00817470007442SMARTSTITCH SUTURE CART. - ASSOR
20817470007439SMARTSTITCH SUTURE CRT MW BLACK
00817470007428OM-8077EA BLK SMARTSTITCH MAGNUMWIRE
20817470007415SMARTSTITCH SUTURE CART.
00817470007404OM-8076EA CO-BRAID SMARTSTITCH MAGNUMWIR
20817470007392SMARTSTITCH WITH MW WHITE
00817470007381SMARTSTITCH WITH MW WHITE
00817470005912SMARTSTITCH NEEDLE CASSETTE
00817470005905SPEEDSTITCH SUTURE CARTRIDGE FIN
20817470005893SPEEDSTITCH SUTURE CARTRIDGE FIN
00817470005882OM-8086EA SPEEDSTITCH SUTURE CARTRIDGE F
20817470005879SPEEDSTITCH SUTURE CARTRIDGE FIN
00817470005868OM-8085EA SPEEDSTITCH SUTURE CARTRIDGE F
00817470005714SMARTSTITCH M-CONNECTOR PKG. ASS
20817470001048SPEEDSTITCH SC W/BLACK COBRAID MAGWIRE
00817470001037SPEEDSTITCH SUTURE CARTRIDGE WITH BLACK

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