Home GUDID 00817470001679 SMARTSTITCH
Primary DI 00817470001679
Brand SMARTSTITCH
Company Smith & Nephew, Inc.
Model OM-8000
Catalog number OM-8000
Device description SMARTSTITCH SUTURE DEVICE HANDLE
Published 2017-11-13
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name NBH ACCESSORIES,ARTHROSCOPIC
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NBH Accessories, Arthroscopic Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00817470001679 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00817470001679 00817470001679 817470001679 0817470001679
GMDN Terms# Term, Definition table Term Definition Suturing unit, reusable A non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft; it may in addition knot and/or cut the sutures as they are placed. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 045483575 Device count 1 Lot or batch true No natural rubber latex true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00198506094170 ELMED INCORPORATED ELMED INCORPORATED NBH 2026-08-18 07630345716743 SportsMed Instruments Medacta International SA NBH 2026-08-17 07630345716750 SportsMed Instruments Medacta International SA NBH 2026-08-17 B382SD319590 Surgical Direct Surgical Direct, Inc. NBH 2026-08-03 B382SD480084LH0 Surgical Direct Surgical Direct, Inc. NBH 2026-08-03 B382SD48008SLH0 Surgical Direct Surgical Direct, Inc. NBH 2026-08-03 B382SD481014SLH0 Surgical Direct Surgical Direct, Inc. NBH 2026-08-03 B382SD481022LH0 Surgical Direct Surgical Direct, Inc. NBH 2026-08-03 B382SD481752CBDYN0 Surgical Direct Surgical Direct, Inc. NBH 2026-08-03 B382SD481752PT0 Surgical Direct Surgical Direct, Inc. NBH 2026-08-03 B382SD481755STR0 Surgical Direct Surgical Direct, Inc. NBH 2026-08-03 B382SD481756STR0 Surgical Direct Surgical Direct, Inc. NBH 2026-08-03 B382SD481760DYN0 Surgical Direct Surgical Direct, Inc. NBH 2026-08-03 B382SD483003STR0 Surgical Direct Surgical Direct, Inc. NBH 2026-08-03 B382SD487193000 Surgical Direct Surgical Direct, Inc. NBH 2026-08-03 B382SD487223000 Surgical Direct Surgical Direct, Inc. NBH 2026-08-03 B382SD5235320 Surgical Direct Surgical Direct, Inc. NBH 2026-08-03 B382SD142090 Surgical Direct Surgical Direct, Inc. NBH 2026-07-31 B382SD1814DK70 Surgical Direct Surgical Direct, Inc. NBH 2026-07-31 B382SD18252590 Surgical Direct Surgical Direct, Inc. NBH 2026-07-31 B382SD30609CH0 Surgical Direct Surgical Direct, Inc. NBH 2026-07-31 B382SD316390 Surgical Direct Surgical Direct, Inc. NBH 2026-07-31 00198506093258 ELMED INCORPORATED ELMED INCORPORATED NBH 2026-07-28 00810143908534 SURGIPROS Surgipros, LLC NBH 2026-07-28 00810143909449 SURGIPROS Surgipros, LLC NBH 2026-07-28 00810143909456 SURGIPROS Surgipros, LLC NBH 2026-07-28 00810143909463 SURGIPROS Surgipros, LLC NBH 2026-07-28 00810143909470 SURGIPROS Surgipros, LLC NBH 2026-07-28 00810143909487 SURGIPROS Surgipros, LLC NBH 2026-07-28 00810143909494 SURGIPROS Surgipros, LLC NBH 2026-07-28
smith-nephew.com