Home GUDID 10841436125939 Needle Guide
Primary DI 10841436125939
Brand Needle Guide
Company CIVCO MEDICAL INSTRUMENTS CO., INC.
Model 857-004
Catalog number 857-004, 857-004-5
Device description Sterile endocavity needle guide for use with Samsung Medison EA2-11AR/EA2-11AV transducers One-cell MEA = 80% embryos developed to epanded blastocyst at 96 hours USP Endotoxin (LAL) tested and passed with 20 EU or less per device
Published 2026-07-27
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 ITX Transducer, ultrasonic, diagnostic MQE NEEDLE, ASSISTED REPRODUCTION
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ITX Transducer, Ultrasonic, Diagnostic Radiology 2 MQE Needle, Assisted Reproduction Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00841436125932 Package GS1 24 In Commercial Distribution 00841436125949 Package GS1 5 In Commercial Distribution 10841436125939 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 00841436125932 00841436125932 841436125932 0841436125932 00841436125949 00841436125949 841436125949 0841436125949 10841436125939 10841436125939
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 00841436122078 Biopsy Bracket CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-27 00841436122900 Biopsy Bracket CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-27 00841436124294 Biopsy Bracket CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-27 00841436125895 Needle Guide Starter Kit CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-27 00841436126052 Biopsy Bracket CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-27 00841436126403 Needle Guide Starter Kit CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-27 00841436126410 Needle Guide Bracket CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-27 00841436127028 Verza Guidance System CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-27 00841436127035 Biopsy Bracket CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-27 10841436125311 CIV-Clear™ Transducer Cover CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-27 10841436125915 Needle Guide CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-27 10841436125915 Needle Guide CIVCO MEDICAL INSTRUMENTS CO., INC. MQE 2026-07-27 10841436125953 Needle Guide CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-27 10841436125953 Needle Guide CIVCO MEDICAL INSTRUMENTS CO., INC. MQE 2026-07-27 10841436127056 Cable Sleeve CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-27 10841436127186 Needle Guide CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-27 00195278713322 RIC12-D GE Healthcare Austria GmbH & Co OG ITX 2026-07-24 04987670106088 CONVEX ARRAY TRANSDUCER CANON INC. ITX 2026-07-24 00841436122061 Verza Guidance System CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-23 00841436125444 Cradle CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-23 00841436125451 Classic Stepper CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-23 00841436125833 Needle Guide Bracket CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-23 00841436125857 Needle Guide Bracket CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-23 00841436126045 Verza Guidance System CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-23 00841436126656 Multi-Purpose Workstation ™ Stepper CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-23 00841436126663 Cradle CIVCO MEDICAL INSTRUMENTS CO., INC. ITX 2026-07-23 00841517112011 iLOOK FUJIFILM SONOSITE, INC. ITX 2026-07-16 00841517112028 iLOOK FUJIFILM SONOSITE, INC. ITX 2026-07-16 00841517112035 iLOOK FUJIFILM SONOSITE, INC. ITX 2026-07-16 00841517112462 iLOOK FUJIFILM SONOSITE, INC. ITX 2026-07-16
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