FDA.reportPublic FDA data

MedOne

Primary DI
10811313013154
Brand
MedOne
Company
MEDONE SURGICAL INC
Model
3315
Catalog number
3315
Device description
3315 MicroDoseTM SF Injection Kit
Published
2023-06-01
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
10811313013154PrimaryGS10
00811313013157Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081131301315410811313013154
00811313013157008113130131578113130131570811313013157

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
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
00811313013058MedOne330533052022-01-07

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00193982458119INSTAFILLGLOBUS MEDICAL, INC.FMF2026-08-14
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00193982504403INSTAFILLGLOBUS MEDICAL, INC.FMF2026-08-14
00884450487402Merit Medical®Merit Medical Systems, Inc.FMF2026-08-07
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