FDA.report

VITAN

Primary DI
05050474651494
Brand
VITAN
Company
JOHNSON & JOHNSON SURGICAL VISION, INC.
Model
DK9000
Catalog number
DK9000
Device description
SMARTLOAD VITAN HANDPIECE
Published
2020-09-01
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
false

Related Records

Contact Domains

Product Codes

CodeName
MFKLens, multifocal intraocular
MSSFolders and injectors, intraocular lens (iol)

Product Code Classifications

CodeDeviceSpecialtyClass
MFKLens, Multifocal IntraocularOphthalmic3
MSSFolders And Injectors, Intraocular Lens (Iol)Ophthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05050474651494PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05050474651494050504746514945050474651494

GMDN Terms

TermDefinition
Manual intraocular lens injector, reusableA hand-held, manual, ophthalmic surgical instrument designed to expel (launch) a prepared folded intraocular lens (IOL) from an attached IOL insertion cartridge into the anterior or posterior chamber of the eye during ophthalmic surgery. Commonly known as the handpiece, this device is used to carefully exert pressure on the prepared IOL to push it out of the IOL insertion cartridge. It is typically made of lightweight metal materials [e.g., titanium (Ti)], has a central plunger that is activated by a precise mechanism (e.g., a screw thread), and has a mechanism at the distal end to hold/grip the insertion cartridge. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(877)266-4543JJV-US-SURGICALORDERS@ITS.JNJ.COM

Regulatory Flags

DUNS number
103021940
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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