Home GUDID 00195278527899 Pristina Paddle
Primary DI 00195278527899
Brand Pristina Paddle
Company GE MEDICAL SYSTEMS
Model SLD 2D PF
Device description Sliding 2D Loc 19x23 Perforated Paddle- Labelled
Published 2022-05-02
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name FMQ Restraint, protective
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FMQ Restraint, Protective General Hospital 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00195278527899 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 00195278527899 00195278527899 195278527899 0195278527899
GMDN Terms# Term, Definition table Term Definition Stationary mammographic x-ray system, digital A stationary assembly of devices designed to generate x-ray images of the breast using digital techniques for image capture and display. It is designed specifically to compress the breast during imaging and is intended to visually evaluate the anatomy and function of blood and lymphatic vessels within the breast. Often referred to as a digital mammography system (DMS) it is typically used for breast cancer screening or during biopsy procedures (e.g., placement of biopsy markers, stereotactic biopsy). It is designed to capture two-dimensional (2-D) x-ray images, however may include software intended to process multiple images to create a three-dimensional (3-D) image/model (tomosynthesis).
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 0 0 Handling Environment Humidity 0 0 Handling Environment Temperature 0 0 Storage Environment Atmospheric Pressure 0 0 Storage Environment Humidity 0 0 Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 266062561 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10080196310128 MEDLINE MEDLINE INDUSTRIES, INC. FMQ 2025-06-03 10748426141125 Medline-Microtek Microtek Medical LLC FMQ 2025-04-08 00195278925428 Pristina Paddle GE MEDICAL SYSTEMS FMQ 2025-01-09 09010279001708 iFIX iSYS Medizintechnik GmbH FMQ 2024-07-30 09010279001715 iFIX iSYS Medizintechnik GmbH FMQ 2024-07-30 10080196281374 Medline MEDLINE INDUSTRIES, INC. FMQ 2024-05-01 M1435040070 Protective Vest No Sleeve Kenad SG Medical, Inc. FMQ 2023-09-17 10190676003232 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-06 10190676003348 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-06 10190676003355 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-06 10190676005441 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-06 10190676005458 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-06 10190676005465 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-06 10190676001016 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676001085 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676001108 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002518 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002525 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002532 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002549 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002556 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002563 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002570 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002594 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002600 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002617 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002624 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002631 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002693 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002709 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05