Home GUDID 00818614022475 itto CSP
Primary DI 00818614022475
Brand itto CSP
Company MEDLINE INDUSTRIES, INC.
Model 51-10001
Device description Continuous Suture Passer
Published 2021-09-24
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 00818614022475 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 00818614022475 00818614022475 818614022475 0818614022475
GMDN Terms# Term, Definition table Term Definition Arthroscopic suturing unit A manually-operated, surgical device intended to be used in combination with a compatible arthroscope to mechanically approximate the edges of an internal wound or incision, including muscle tears, with sutures during arthroscopy. A suture punch mechanism places the number of sutures desired by the surgeon at the site of the lesion. This is a reusable device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 025460908 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label 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