FDA.report

COMPLETE

Primary DI
00827444000751
Brand
COMPLETE
Company
JOHNSON & JOHNSON SURGICAL VISION, INC.
Model
93586HZ
Catalog number
93586HZ
Device description
COMPLETE 60 ML RETAIL
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LPNAccessories, Soft Lens Products

Product Code Classifications

CodeDeviceSpecialtyClass
LPNAccessories, Soft Lens ProductsOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20827444000755PackageGS16In Commercial Distribution
30827444000752PackageGS14In Commercial Distribution
00827444000751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2082744400075520827444000755
3082744400075230827444000752
00827444000751008274440007518274440007510827444000751

GMDN Terms

TermDefinition
Multi-purpose soft contact lens solutionA sterile aqueous formulation containing appropriate agents typically for cleaning, rinsing, protein removal, disinfecting, storing, and possibly wetting reusable soft contact lenses. The solution may be specific to a type of procedure (e.g., manual, heated, or ultrasonic). After application, this device cannot be reused.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)266-4543JJV-US-EYEHEALTH@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
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

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05050474806283PURESEE IOLDEN00VDEN00VU1152026-03-16
05050474806290PURESEE IOLDEN00VDEN00VU1202026-03-16
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05050474806313PURESEE IOLDEN00VDEN00VU1302026-03-16
05050474806320PURESEE IOLDEN00VDEN00VU1352026-03-16
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