Home GUDID 23700773723908 PRECIVIA® Version I
Primary DI 23700773723908
Brand PRECIVIA® Version I
Company FCI S A S FCI 20 22
Model S5.200.I
Device description A rigid, non-powered device designed to lead a 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 many different procedures such as guides for urethral injections, guides for transrectal prostate biopsy, image-guided (e.g., ultrasound, MRI) for percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. Disposable imaging-supportive devices (e.g., ultrasound transducer cover/gel) may be included with the device. This is a single-use device.
Published 2021-05-25
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 HNC Specula, Ophthalmic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HNC Specula, Ophthalmic Ophthalmic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 23700773723908 Package GS1 25 In Commercial Distribution 13700773723901 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 23700773723908 23700773723908 13700773723901 13700773723901
GMDN Terms# Term, Definition table Term Definition Nonimplantable needle guide, single-use A rigid, non-powered device designed to lead a 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 many different procedures such as guides for urethral injections, guides for transrectal prostate biopsy, image-guided (e.g., ultrasound, MRI) for percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. Disposable imaging-supportive devices (e.g., ultrasound transducer cover/gel) may be included with the device. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 10 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 763408366 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false 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 false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 13700773729651 STOPLOSS® JONES TUBE 3,5 X 9 MM S1.7309 2026-04-20 13700773729668 STOPLOSS® JONES TUBE 3,5 X 10 MM S1.7310 2026-04-20 13700773729675 STOPLOSS® JONES TUBE 3,5 X 11 MM S1.7311 2026-04-20 13700773729682 STOPLOSS® JONES TUBE 3,5 X 12 MM S1.7312 2026-04-20 13700773729699 STOPLOSS® JONES TUBE 3,5 X 13 MM S1.7313 2026-04-20 13700773730817 STOPLOSS® JONES TUBE INTRODUCER SET S1.7500 2026-04-20 13700773731920 STOPLOSS® JONES TUBE 3,5 X 14 MM S1.7314 2026-04-20 13700773731937 STOPLOSS® JONES TUBE 3,5 X 15 MM S1.7315 2026-04-20 13700773731968 STOPLOSS® JONES TUBE 3,5 X 16 MM S1.7316 2026-04-20 13700773731975 STOPLOSS® JONES TUBE 3,5 X 17 MM S1.7317 2026-04-20 13700773731982 STOPLOSS® JONES TUBE 3,5 X 18 MM S1.7318 2026-04-20 13700773731999 STOPLOSS® JONES TUBE 3,5 X 19 MM S1.7319 2026-04-20 13700773732002 STOPLOSS® JONES TUBE 3,5 X 20 MM S1.7320 2026-04-20 13700773732019 STOPLOSS® JONES TUBE 3,5 X 21 MM S1.7321 2026-04-20 13700773732026 STOPLOSS® JONES TUBE 3,5 X 22 MM S1.7322 2026-04-20 13700773732033 STOPLOSS® JONES TUBE 4 X 9 MM S1.7409 2026-04-20 13700773732040 STOPLOSS® JONES TUBE 4 X 10 MM S1.7410 2026-04-20 13700773732057 STOPLOSS® JONES TUBE 4 X 11 MM S1.7411 2026-04-20 13700773732064 STOPLOSS® JONES TUBE 4 X 12 MM S1.7412 2026-04-20 13700773732071 STOPLOSS® JONES TUBE 4 X 13 MM S1.7413 2026-04-20
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08175700102636 Ophthalmic Speculum AURORA SURGICAL, LLC HNC 2024-01-10 08175700102643 Ophthalmic Speculum AURORA SURGICAL, LLC HNC 2024-01-10 08175700102650 Ophthalmic Speculum AURORA SURGICAL, LLC HNC 2024-01-10 08175700100489 Ophthalmic Speculum AURORA SURGICAL, LLC HNC 2024-01-09 08175700100571 Ophthalmic Speculum AURORA SURGICAL, LLC HNC 2024-01-09 08175700102605 Ophthalmic Speculum AURORA SURGICAL, LLC HNC 2024-01-09 08175700102612 Ophthalmic Speculum AURORA SURGICAL, LLC HNC 2024-01-09 08175700102629 Ophthalmic Speculum AURORA SURGICAL, LLC HNC 2024-01-09 G346E12150 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2023-02-13 G346E1253R0 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-19 G346E1254L0 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-19 G346E1254R0 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-19 G346E11250 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E11260 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E11440 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E11490 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E11560 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E12010 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E12020 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E12030 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E12050 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E12060 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E12070 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E12100 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E12210 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E1230 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E1253L0 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E12650 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E145K0 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E1460 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16