Home GUDID 13700773723918 PRECIVIA® Version P
Primary DI 13700773723918
Brand PRECIVIA® Version P
Company FCI S A S FCI 20 22
Model S5.200.P
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 Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
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 23700773723915 Package GS1 25 In Commercial Distribution 13700773723918 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 23700773723915 23700773723915 13700773723918 13700773723918
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 Handling Environment Temperature 10 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 763408366 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label true 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