FDA.reportPublic FDA data

MedOne

Primary DI
10811313012751
Brand
MedOne
Company
MEDONE SURGICAL INC
Model
3275
Catalog number
3275
Device description
MicroDose™ Injector
Published
2020-05-08
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203264000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203264000MicroDose InjectorMedone Surgical, Inc.2021-04-26FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10811313012751PrimaryGS10
00811313012754Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081131301275110811313012751
00811313012754008113130127548113130127540811313012754

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-useA rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing or a basic handle (without controls). It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
941.359.3129medone@medone.com

Regulatory Flags#

DUNS number
004626680
Device count
5
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10811313013161MedOne331633162025-08-25
10811313013307MedOne333033302025-08-26
10811313013314MedOne333133312025-08-26
00811313013300MedOne333033302025-08-26
00811313013317MedOne333133312025-08-26
00811313013164MedOne331633162025-08-25
10811313013154MedOne331533152023-06-01
00811313013157MedOne331533152023-06-01
10811313012669MedOne326632662020-05-08
10811313012683MedOne326832682020-05-08
10811313012690MedOne 326932692020-05-08
10811313012720MedOne327232722020-05-08
10811313013192MedOne331933192022-08-24
00811313013195MedOne331933192022-08-24
10811313013079MedOne330733072022-01-20
10811313013086MedOne330833082022-01-20
00811313013072MedOne330733072022-01-20
00811313013089MedOne330833082022-01-20
10811313013055MedOne330533052022-01-07
10811313013062MedOne330633062022-01-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391530753968FD-1019NS - 1ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088FD-1021NS 3ml PC Syringe White PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754194FD-1034NS 20ml PC Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754224FD-1033NS 20ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231FD-1092NS 20ml PC Syringe Heparin Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456FD-1032NS - 20ml PC Syringe Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463FD-1031NS - 20ml PC Syringe White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753487FD-1113NS - 10ml PC Syringe Contrast Dark Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753517FD-1051NS - 10ml PC Syringe Purple Plunger - Lidocaine PrintDMC MEDICAL LIMITEDFMF2026-06-01
05391530753524FD-1043NS - 10ml PC Syringe - Contrast - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753531FD-1107NS - 30ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753548FD-1026NS - 10ml PC Syringe - White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753555FD-1158NS - 10ml PC Syringe - Heparin/Saline White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753562FD-1049NS - 10ml PC Syringe - Lidocaine Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753579FD-1029NS - 10ml PC Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753593FD-1054NS - 10ml PC Syringe - Nitro Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753609FD-1039NS - 10ml PC Syringe - Heparin Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753616FD-1071NS - 10ml PC Syringe - Purple PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753623FD-1028NS - 10ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753647FD-1072NS - 10ml PC Syringe Dark Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753654FD-1030NS - 10ml PC Syringe - Light Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753661FD-1042NS - 10ml PC Syringe - Contrast Print - Light Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753678FD-1044NS - 10ml PC Syringe - Contrast Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753685FD-1045NS - 10ml PC Syringe - Contrast Print - White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753692FD-1046NS - 10ml PC Syringe Contrast Light Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753708FD-1047NS - 10ml PC Syringe - Lidocaine Print - Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753715FD-1103NS - 20ml PC Syringe - Purple PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753722FD-1027NS - 10ml PC Syringe Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753753FD-1067NS - 3ml PC Syringe - Nitro Print - Purple PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753760FD-1038NS - 10ml PC Syringe Heparin Print Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01