FDA.reportPublic FDA data

MedOne

Primary DI
00811313012754
Brand
MedOne
Company
MEDONE SURGICAL INC
Model
3275
Catalog number
3275
Device description
MicroDose™ Injection Kit
Published
2020-05-08
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston
KDDKit, Surgical Instrument, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
KDDKit, Surgical Instrument, DisposableGeneral, Plastic Surgery1

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
941.359.3129medone@medone.com

Regulatory Flags#

DUNS number
004626680
Device count
5
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
false

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160541739HALYARDMEDICAL ACTION INDUSTRIES INC.KDD2026-10-26
06934841531291TKMDAnhui Tiankang Medical Technology Co., Ltd.FMF2026-10-23
00850074437208OftalOnePackOFTAL-ONE INC.KDD2026-10-21
MHC182332552EasyTouchMHC MEDICAL PRODUCTS, LLCFMF2026-10-21
09347144013062Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144013123Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144015004Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016186Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016216Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
20612479288496McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
20612479288526McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
10304040193843Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193850Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
00850091070532CoreCareCorecare Products Inc.FMF2026-09-11
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00850091070655CoreCareCorecare Products Inc.FMF2026-09-11
00850091070679CoreCareCorecare Products Inc.FMF2026-09-11
10816336022671NC603500-ENFNEOCHILD, LLCFMF2026-09-10
00850091070242CoreCareCorecare Products Inc.FMF2026-09-04
00850091070372CoreCareCorecare Products Inc.FMF2026-09-04
00850091070389CoreCareCorecare Products Inc.FMF2026-09-04
00850091070396CoreCareCorecare Products Inc.FMF2026-09-04
00850091070402CoreCareCorecare Products Inc.FMF2026-09-04
00850091070419CoreCareCorecare Products Inc.FMF2026-09-04
00850091070426CoreCareCorecare Products Inc.FMF2026-09-04
00850091070433CoreCareCorecare Products Inc.FMF2026-09-04