Home GUDID 00841436123068 Needle Guide
Primary DI 00841436123068
Brand Needle Guide
Company CIVCO MEDICAL INSTRUMENTS CO., INC.
Model 842-004
Catalog number 842-004, 842-004-5
Device description Sterile endocavity needle guide for use with GE Healtcare RIC5-9-D, RIC5-9W-RS. RIC6-12-D and Samsung Medison EV3-10B, V5-9 transducers. One-cell MEA: =80% embryo developed to expand cytoblast at 96 hours USP Endotoxin (LAL) tested and passed with 20 EU or less per device.
Published 2024-06-20
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name MQE NEEDLE, ASSISTED REPRODUCTION
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MQE Needle, Assisted Reproduction Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00841436122245 Package GS1 24 In Commercial Distribution 00841436123068 Package GS1 5 In Commercial Distribution 10841436122242 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 00841436122245 00841436122245 841436122245 0841436122245 00841436123068 00841436123068 841436123068 0841436123068 10841436122242 10841436122242
GMDN Terms# Term, Definition table Term Definition Needle guide, single-use A rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep Away from Sunlight
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 134614411 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false 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 10841436122211 Needle Guide CIVCO MEDICAL INSTRUMENTS CO., INC. MQE 2024-06-20 10841436122228 Needle Guide CIVCO MEDICAL INSTRUMENTS CO., INC. MQE 2024-06-20 10841436122242 Needle Guide CIVCO MEDICAL INSTRUMENTS CO., INC. MQE 2024-06-20 10841436122266 Needle Guide CIVCO MEDICAL INSTRUMENTS CO., INC. MQE 2024-06-20 10841436122273 Needle Guide CIVCO MEDICAL INSTRUMENTS CO., INC. MQE 2024-06-20 10841436122297 Needle Guide CIVCO MEDICAL INSTRUMENTS CO., INC. MQE 2024-06-20 10841436122310 Needle Guide CIVCO MEDICAL INSTRUMENTS CO., INC. MQE 2024-06-20 10841436122334 Needle Guide CIVCO MEDICAL INSTRUMENTS CO., INC. MQE 2024-06-20 10841436122358 Needle Guide CIVCO MEDICAL INSTRUMENTS CO., INC. MQE 2024-06-20 10841436122365 Needle Guide CIVCO MEDICAL INSTRUMENTS CO., INC. MQE 2024-06-20 10841436123225 Needle Guide CIVCO MEDICAL INSTRUMENTS CO., INC. MQE 2024-06-20 10841436123249 Needle Guide CIVCO MEDICAL INSTRUMENTS CO., INC. MQE 2024-06-20 04580745043709 OPU Needle KITAZATO CORPORATION MQE 2024-05-16 04580745043723 OPU Needle KITAZATO CORPORATION MQE 2024-05-16 04580745043730 OPU Needle KITAZATO CORPORATION MQE 2024-05-16 03700111400801 HOC CLASSIC WITH VALVE Aspiration tube 2 x 33 cm LABORATOIRE CCD MQE 2023-12-05 03700111400818 HOC CLASSIC WITHOUT VALVE Aspiration tube 67 cm LABORATOIRE CCD MQE 2023-12-05 03700111400825 HOC2 CLASSIC WITHOUT VALVE SOFT PLUG LABORATOIRE CCD MQE 2023-12-05 03700111400832 OPS CLASSIC WITHOUT VALVE LABORATOIRE CCD MQE 2023-12-05 03700111400849 OPS CLASSIC WITH VALVE LABORATOIRE CCD MQE 2023-12-05 03700111400863 HOC COLLECTION VIAL 30ML LABORATOIRE CCD MQE 2023-12-05 03700111400917 OPS A.R.T. OF C.C.D. ® WITHOUT VALVE LABORATOIRE CCD MQE 2023-12-05 03700111400924 OPS A.R.T. OF C.C.D. ®WITH VALVE LABORATOIRE CCD MQE 2023-12-05 03700111400931 HOC A.R.T. OF C.C.D.® WITHOUT VALVE LABORATOIRE CCD MQE 2023-12-05 03700111400948 HOC A.R.T. OF C.C.D.® WITH VALVE LABORATOIRE CCD MQE 2023-12-05 03700111400955 HOC2 A.R.T. OF C.C.D.® WITHOUT VALVE SOFT PLUG LABORATOIRE CCD MQE 2023-12-05 03700111400962 HOC2 A.R.T. OF C.C.D. ®WITH VALVE SOFT PLUG LABORATOIRE CCD MQE 2023-12-05 03700111400979 OVO A.R.T. OF C.C.D.® NEEDLE 30CM G17 LABORATOIRE CCD MQE 2023-12-05 03700111400993 OOCYTE RETRIEVAL NEEDLE30CM G17 LABORATOIRE CCD MQE 2023-12-05 03700111401006 OOCYTE RETRIEVAL NEEDLE 25CM G17 LABORATOIRE CCD MQE 2023-12-05
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