Home GUDID 00860000540544 Orbit Subretinal Delivery System
Primary DI 00860000540544
Brand Orbit Subretinal Delivery System
Company Gyroscope Usa, Inc.
Model PN1007130
Device description Pouched Syringe Kit
Published 2019-04-30
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 FMF Syringe, Piston HMX Cannula, Ophthalmic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FMF Syringe, Piston General Hospital 2 HMX Cannula, Ophthalmic Ophthalmic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860000540544 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 00860000540544 00860000540544 860000540544 0860000540544
GMDN Terms# Term, Definition table Term Definition Ophthalmic surgical procedure kit, non-medicated, single-use A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.
Regulatory Flags# DUNS number 071418804 Device count 1 Kit 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 00850009362001 Orbit Subretinal Delivery System PN1008904-001 2020-09-29 00850009362018 Orbit Subretinal Delivery System PN1008919-001 2020-09-29 00850009362025 Orbit Subretinal Delivery System PN1008927-001 2020-09-29 00850009362032 Orbit Subretinal Delivery System PN1008946-001 2020-09-29 00860000540506 Orbit Subretinal Delivery System PN1007128-002 2019-04-30 00860000540513 Orbit Subretinal Delivery System PN1007128-002C 2019-04-30 00860000540520 Orbit Subretinal Delivery System PN1007138 2019-04-30 00860000540537 Orbit Subretinal Delivery System PN1007138C 2019-04-30 00860000540551 Orbit Subretinal Delivery System PN1007256 2019-04-30 00860000540568 Orbit Subretinal Delivery System JANS0030 2019-04-30
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 04251047903151 Nagahara Phaco-Chopper A1 Medical GmbH HMX 2026-06-09 04251047903175 Nagahara Phaco-Chopper A1 Medical GmbH HMX 2026-06-09 04251047903632 Chang Phaco Chopper A1 Medical GmbH HMX 2026-06-09 04251047903755 Nagahara Phaco-Chopper A1 Medical GmbH HMX 2026-06-09 05391530753944 FD-1017NS - 1ml PC Syringe - White Plunger DMC MEDICAL LIMITED FMF 2026-06-03 05391530753951 FD-1018NS - 1ml PC Syringe - Blue Plunger DMC MEDICAL LIMITED FMF 2026-06-03 05391530754217 FD-1078NS 20ml PC Syringe - White Plunger - Saline Print DMC MEDICAL LIMITED FMF 2026-06-03 05391530754620 FD-1048NS 10ml PC Syringe Yellow Plunger Lidocaine DMC MEDICAL LIMITED FMF 2026-06-03 05391530754699 FD-1075NS 10ml PC Syringe Light Blue Plunger Xylocaine DMC MEDICAL LIMITED FMF 2026-06-03 05391530754941 FD-1180NS 3ml Nugen Syringe Red Plunge DMC MEDICAL LIMITED FMF 2026-06-03 05391530754965 FD-1162NS 10ml Nugen Syringe Red Plunger DMC MEDICAL LIMITED FMF 2026-06-03 05391530753968 FD-1019NS - 1ml PC Syringe - Yellow Plunger DMC MEDICAL LIMITED FMF 2026-06-02 05391530754088 FD-1021NS 3ml PC Syringe White Plunger DMC MEDICAL LIMITED FMF 2026-06-02 05391530754194 FD-1034NS 20ml PC Syringe Red Plunger DMC MEDICAL LIMITED FMF 2026-06-02 05391530754224 FD-1033NS 20ml PC Syringe - Yellow Plunger DMC MEDICAL LIMITED FMF 2026-06-02 05391530754231 FD-1092NS 20ml PC Syringe Heparin Print - Red Plunger DMC MEDICAL LIMITED FMF 2026-06-02 05391530753456 FD-1032NS - 20ml PC Syringe Blue Plunger DMC MEDICAL LIMITED FMF 2026-06-01 05391530753463 FD-1031NS - 20ml PC Syringe White Plunger DMC MEDICAL LIMITED FMF 2026-06-01 05391530753487 FD-1113NS - 10ml PC Syringe Contrast Dark Green Plunger DMC MEDICAL LIMITED FMF 2026-06-01 05391530753517 FD-1051NS - 10ml PC Syringe Purple Plunger - Lidocaine Print DMC MEDICAL LIMITED FMF 2026-06-01 05391530753524 FD-1043NS - 10ml PC Syringe - Contrast - Yellow Plunger DMC MEDICAL LIMITED FMF 2026-06-01 05391530753531 FD-1107NS - 30ml PC Syringe - Yellow Plunger DMC MEDICAL LIMITED FMF 2026-06-01 05391530753548 FD-1026NS - 10ml PC Syringe - White Plunger DMC MEDICAL LIMITED FMF 2026-06-01 05391530753555 FD-1158NS - 10ml PC Syringe - Heparin/Saline White Plunger DMC MEDICAL LIMITED FMF 2026-06-01 05391530753562 FD-1049NS - 10ml PC Syringe - Lidocaine Print - Red Plunger DMC MEDICAL LIMITED FMF 2026-06-01 05391530753579 FD-1029NS - 10ml PC Syringe Red Plunger DMC MEDICAL LIMITED FMF 2026-06-01 05391530753593 FD-1054NS - 10ml PC Syringe - Nitro Print - Red Plunger DMC MEDICAL LIMITED FMF 2026-06-01 05391530753609 FD-1039NS - 10ml PC Syringe - Heparin Print - Red Plunger DMC MEDICAL LIMITED FMF 2026-06-01 05391530753616 FD-1071NS - 10ml PC Syringe - Purple Plunger DMC MEDICAL LIMITED FMF 2026-06-01 05391530753623 FD-1028NS - 10ml PC Syringe - Yellow Plunger DMC MEDICAL LIMITED FMF 2026-06-01
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