Home GUDID 20811870037706
Manus Medical, LLC
Primary DI 20811870037706
Brand Manus Medical, LLC
Company Manus Medical, LLC
Model ANM-20154
Device description STERILE VIENNA SPECULUM
Published 2023-09-29
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 EPY Speculum, Ent
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EPY Speculum, Ent General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20811870037706 Package GS1 50 In Commercial Distribution 00811870037702 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 20811870037706 20811870037706 00811870037702 00811870037702 811870037702 0811870037702
GMDN Terms# Term, Definition table Term Definition Nasal snare, single-use A hand-held manual surgical instrument intended to be inserted into the naris for the removal of tissue, typically polyps, tumours, and other abnormal tissue from the nasal cavity during ear/nose/throat (ENT) surgery. It typically consists of a cannula-like tube with two stationary and one sliding finger rings designed to position and tighten a loop of thin, flexible wire (the snare) around the tissue to be removed. It is intended for mechanical cutting only (i.e., not through electrical ablation). This is a single-use device.
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 800604196 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00811870037979 Manus Medical, LLC ZZ-0683-1 2024-02-06 00811870033216 Custom Healthcare Systems Inc. UNC-17914 2018-07-25 00811870035555 Custom Healthcare Systems of VA, LLC CLT-19914 2021-06-18 00811870030703 Custom Healthcare Systems Inc. VBS-18520C 2018-10-19 00811870032943 CUSTOM HEALTHCARE SYSTEMS, INC DT-052019 2019-06-03 00811870034411 Custom Healthcare Systems Inc. VBS-18520B 2018-10-19 00811870035036 Custom Healthcare Systems, Inc. DT-19714 2020-04-09 00811870035166 Custom Healthcare Systems, Inc. CUS1365-02 2020-07-28 00811870035630 Custom Healthcare Systems of VA, LLC DT-19714 v2 2021-07-12 00811870035661 Custom Healthcare Systems of VA, LLC DT-19343 2021-07-15 00811870035883 Custom Healthcare Systems Inc. VBS-19108 2019-03-07 00811870035890 Custom Healthcare Systems Inc. 1116803015 2019-03-07 00811870037863 Manus Medical, LLC EMLP-20375-1 2023-12-20 00811870037986 Manus Medical, LLC UNC-9800-0 2024-02-07 20811870037980 Manus Medical, LLC UNC-9800-0 2024-02-07 20811870037973 Manus Medical, LLC ZZ-0683-1 2024-02-06 00811870037887 Manus Medical, LLC LPGM-001 2024-02-02 00811870037900 Manus Medical, LLC LPGM-002-1 2024-02-02 00811870037917 Manus Medical, LLC MMCUS1173 2024-02-02 00811870037924 Manus Medical, LLC A2081V-7 2024-02-02
Other Devices Sharing Product Codes#