Home GUDID 00082161107019 Plastalume
Primary DI 00082161107019
Brand Plastalume
Company BROWNMED, INC.
Model 10701
Device description Stax-Mallets
Published 2020-08-14
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
Single use false Product Codes# Code, Name table Code Name FYH Splint, Extremity, Noninflatable, External, Sterile
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FYH Splint, Extremity, Noninflatable, External, Sterile General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00082161107019 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 00082161107019 00082161107019 082161107019 0082161107019
GMDN Terms# Term, Definition table Term Definition Hand/finger splint, reusable A non-sterile rigid or semi-rigid device that is used to immobilize an injured hand to protect injuries to, e.g., the digits, metacarpals, and wrist during the healing process. It is applied externally to the hand/finger/wrist and is held in place with, e.g., self-retaining Velcro bands. This is a reusable device.
Regulatory Flags# DUNS number 091999771 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 false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex true 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 00026072012208 SC Allied Medical, LLC FYH 2024-05-09 00026072022771 SC Allied Medical, LLC FYH 2024-05-09 00026072022788 SC Allied Medical, LLC FYH 2024-05-09 00026072022795 SC Allied Medical, LLC FYH 2024-05-09 00026072022801 SC Allied Medical, LLC FYH 2024-05-09 00026072022818 SC Allied Medical, LLC FYH 2024-05-09 00026072022825 SC Allied Medical, LLC FYH 2024-05-09 00026072022894 SC Allied Medical, LLC FYH 2024-05-09 00026072022900 SC Allied Medical, LLC FYH 2024-05-09 10861887000210 INRO Surgical Nail Inro Medical Designs Inc FYH 2023-08-17 00817612020964 Dale Strapless Bendable Armboard DALE MEDICAL PRODUCTS, INC. FYH 2020-09-14 00817612020995 Dale Strapless Bendable Armboard DALE MEDICAL PRODUCTS, INC. FYH 2020-09-14 00817612021015 Dale Strapless Bendable Armboard DALE MEDICAL PRODUCTS, INC. FYH 2020-09-14 00082161503118 Nice Stretch BROWNMED, INC. FYH 2020-08-17 00082161503125 Nice Stretch BROWNMED, INC. FYH 2020-08-17 00082161503200 Nice Stretch BROWNMED, INC. FYH 2020-08-17 00082161510000 Nice Stretch BROWNMED, INC. FYH 2020-08-17 00082161510017 Nice Stretch BROWNMED, INC. FYH 2020-08-17 00082161510024 Nice Stretch BROWNMED, INC. FYH 2020-08-17 00082161510031 Nice Stretch BROWNMED, INC. FYH 2020-08-17 00082161510208 Nice Stretch BROWNMED, INC. FYH 2020-08-17 00082161510215 Nice Stretch BROWNMED, INC. FYH 2020-08-17 00082161510222 Nice Stretch BROWNMED, INC. FYH 2020-08-17 00082161510239 Nice Stretch BROWNMED, INC. FYH 2020-08-17 00082161510307 Nice Stretch BROWNMED, INC. FYH 2020-08-17 00082161510314 Nice Stretch BROWNMED, INC. FYH 2020-08-17 00082161510321 Nice Stretch BROWNMED, INC. FYH 2020-08-17 00082161510338 Nice Stretch BROWNMED, INC. FYH 2020-08-17 00082161520603 Nice Stretch BROWNMED, INC. FYH 2020-08-17 00082161520610 Nice Stretch BROWNMED, INC. FYH 2020-08-17