FDA.reportPublic FDA data

MedOne

Primary DI
00811313013157
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
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

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.

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
false
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
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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Primary DI, Brand, Company table
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