FDA.reportPublic FDA data

NA

Primary DI
30818255010726
Brand
NA
Company
MICROVISION, INC.
Model
NA
Catalog number
5177
Device description
Fiber Optic Illuminator, 23Ga. - ALN
Published
2018-01-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FFSImage, Illumination, Fiberoptic, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFSImage, Illumination, Fiberoptic, For Endoscope Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K982462000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982462000FIBER OPTIC ENDOILLUMINATION PROBEMicrovision, Inc.1998-09-14FFS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30818255010726PackageGS15In Commercial Distribution
10818255010722PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081825501072630818255010726
1081825501072210818255010722

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic fibreoptic light instrument, single-useA sterile, hand-held, ophthalmic surgical instrument with a thin, rigid, insertion portion, that is inserted into the eye during a surgical intervention for the purpose of conducting a field of cold light to the posterior segment of the eye. It is connected through a permanently attached light cable to a light source. It has a fibreoptic bundle core that conducts the light, and may be provided with an atraumatic tip to allow for extraocular manipulation (orbital depression) with transscleral illumination. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0.6Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from direct sunlight

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
013486803
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
10818255011194NAStyle 50354032017-12-22
10818255011200NAStyle 50454042017-12-22
10818255011217NAStyle 50554052017-12-22
10818255011224NAStyle 50654072017-12-22
10818255011231NAStyle 50754082017-12-22
10818255011323NAStyle 27754312017-12-22
10818255011330NAStyle 27954322017-12-22
10818255011378NAStyle 27654382017-12-22
10818255011385NAStyle 28654402017-12-22
10818255011392NAStyle 28754412017-12-22
10818255011415NAStyle 24054452017-12-22
10818255011422NAStyle 27054462017-12-22
10818255011439NAStyle 7054472017-12-22
10818255011446NAStyle 4854482017-12-22
10818255011453NAStyle 4054492017-12-22
10818255011460NAStyle 4254502017-12-22
10818255011491NAStyle 10654542017-12-22
10818255011521NAStyle 11254602017-12-22
30818255011198NAStyle 50354032017-12-22
30818255011204NAStyle 50454042017-12-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD512531140Surgical DirectSurgical Direct, Inc.FFS2026-02-03
B382SD77321140Surgical DirectSurgical Direct, Inc.FFS2026-02-03
B382SD97321140Surgical DirectSurgical Direct, Inc.FFS2026-02-02
B382SD97321150Surgical DirectSurgical Direct, Inc.FFS2026-02-02
B382SD97331160Surgical DirectSurgical Direct, Inc.FFS2026-02-02
B382SD51531140Surgical DirectSurgical Direct, Inc.FFS2025-12-02
B382SD65331140Surgical DirectSurgical Direct, Inc.FFS2025-12-02
B382SD67511170Surgical DirectSurgical Direct, Inc.FFS2025-06-04
B382SD95321140Surgical DirectSurgical Direct, Inc.FFS2025-06-04
B382SD84531130Surgical DirectSurgical Direct, Inc.FFS2025-04-03
B382SD92422150Surgical DirectSurgical Direct, Inc.FFS2025-03-17
B382SD512531150Surgical DirectSurgical Direct, Inc.FFS2025-03-10
00857580006829Fiber Optic Light CableGULF FIBEROPTICS, INC.FFS2025-02-26
B382SD123200Surgical DirectSurgical Direct, Inc.FFS2024-12-12
00821925008892GYRUS ACMI, INCGyrus ACMI, LLCFFS2024-11-25
00857580006812Fiber Optic Light CableGULF FIBEROPTICS, INC.FFS2024-10-15
B382SD52321110Surgical DirectSurgical Direct, Inc.FFS2024-08-08
B382SD82421110Surgical DirectSurgical Direct, Inc.FFS2024-08-01
00857580006805Fiber Optic Light CableGULF FIBEROPTICS, INC.FFS2024-06-07
B382SD81531140Surgical DirectSurgical Direct, Inc.FFS2024-03-12
B382SD82131160Surgical DirectSurgical Direct, Inc.FFS2024-03-12
B382SD42531170Surgical DirectSurgical Direct, Inc.FFS2024-02-23
B382SD4810450Surgical DirectSurgical Direct, Inc.FFS2024-01-31
B382SD77311150Surgical DirectSurgical Direct, Inc.FFS2023-06-06
B382SD28130Surgical DirectSurgical Direct, Inc.FFS2023-05-16
B382SD57531150Surgical DirectSurgical Direct, Inc.FFS2023-05-08
B382SD81531120Surgical DirectSurgical Direct, Inc.FFS2023-04-24
B382SD3544140Surgical DirectSurgical Direct, Inc.FFS2023-04-06
B382SD91531140Surgical DirectSurgical Direct, Inc.FFS2023-04-06
00857580006782Fiber Optic Light CableGULF FIBEROPTICS, INC.FFS2023-03-06