Home GUDID 00385640035071 N/A
Primary DI 00385640035071
Brand N/A
Company Summit Medical, Inc.
Model PH-1000
Published 2018-03-07
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name KCJ Applicator, Ent
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KCJ Applicator, Ent Ear, Nose, Throat 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10385640035078 Package GS1 10 In Commercial Distribution 00385640035071 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 10385640035078 10385640035078 00385640035071 00385640035071 385640035071 0385640035071
GMDN Terms# Term, Definition table Term Definition Cotton pledget applicator, single-use A slender rod of wood, flexible metal, or synthetic material with a pledget of cotton attached at one end intended to be used for cleaning or applying a substance (e.g., medication) to superficial wounds or body orifices [e.g., ears, nose, oral cavity, throat, anus, rectum]. This is a single-use device.
Regulatory Flags# DUNS number 965484699 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00757770410972 Bausch + Lomb Bausch & Lomb Incorporated KCJ 2025-07-29 00757770420179 Bausch + Lomb Bausch & Lomb Incorporated KCJ 2025-07-29 00757770420766 Bausch + Lomb Bausch & Lomb Incorporated KCJ 2025-07-29 00757770427383 Bausch + Lomb Bausch & Lomb Incorporated KCJ 2025-07-29 00850027492698 Naväge Rhinosystems, Inc. KCJ 2024-11-15 00887482037898 Symmetry Farrell ASPEN SURGICAL PRODUCTS, INC. KCJ 2024-08-15 00840183517489 BR Surgical, LLC BR Surgical, LLC KCJ 2024-05-29 04055207009734 NA Richard Wolf GmbH KCJ 2024-05-21 00850022483073 Saline Noze Mist Dr. Noze Best, LLC KCJ 2024-02-05 G586E1032750 Novo Surgical NOVO SURGICAL, INC. KCJ 2023-12-18 G586E1035960 Novo Surgical NOVO SURGICAL, INC. KCJ 2023-12-18 G586E91032250 Novo Surgical NOVO SURGICAL, INC. KCJ 2023-12-18 G586E91032270 Novo Surgical NOVO SURGICAL, INC. KCJ 2023-12-18 G586E91032290 Novo Surgical NOVO SURGICAL, INC. KCJ 2023-12-18 G586E91032750 Novo Surgical NOVO SURGICAL, INC. KCJ 2023-12-18 G586E91032770 Novo Surgical NOVO SURGICAL, INC. KCJ 2023-12-18 G586E91032790 Novo Surgical NOVO SURGICAL, INC. KCJ 2023-12-18 G586E91035460 Novo Surgical NOVO SURGICAL, INC. KCJ 2023-12-18 G586E91035960 Novo Surgical NOVO SURGICAL, INC. KCJ 2023-12-18 00842331192524 Novo Surgical Inc. NOVO SURGICAL, INC. KCJ 2023-12-07 05060259070426 Sigma Swab MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED KCJ 2023-10-05 05060259070488 Sigma Swab MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED KCJ 2023-10-05 05060259070853 Dryswab MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED KCJ 2023-10-05 05060259070983 Dryswab MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED KCJ 2023-10-05 05060259070990 Dryswab MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED KCJ 2023-10-05 05060259073120 Dryswab MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED KCJ 2023-10-05 05060259073137 Dryswab MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED KCJ 2023-10-05 25060259070420 Sigma Swab MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED KCJ 2023-10-05 45060259070486 Sigma Swab MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED KCJ 2023-10-05 25060259070857 Dryswab MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED KCJ 2023-10-05