FDA.report

HEALON DUET

Primary DI
05050474573574
Brand
HEALON DUET
Company
JOHNSON & JOHNSON SURGICAL VISION, INC.
Model
10290080
Catalog number
10290080
Device description
HEALON DUET US
Published
2014-11-14
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

Related Records

Contact Domains

Product Codes

CodeName
LZPAID, SURGICAL, VISCOELASTIC

Product Code Classifications

CodeDeviceSpecialtyClass
LZPAid, Surgical, ViscoelasticOphthalmic3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05050474573574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05050474573574050504745735745050474573574

GMDN Terms

TermDefinition
Vitreous/aqueous humour replacement medium, intraoperativeA nonimplantable artificial fluid, semifluid, or viscoelastic substance intended to be used to replace the vitreous or aqueous humour within the eye to help facilitate the performance of ophthalmic surgery (e.g., to maintain the shape of the eyeball during the intervention, preserve tissue integrity, protect from surgical trauma, and/or to function as a tamponade during retinal reattachment). It may be supplied in a prefilled sterile syringe or other container. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
103021940
Device count
1
DM exempt
true
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
true
Sterilization required before use
false

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