FDA.report

COMPLETE

Primary DI
20827444000656
Brand
COMPLETE
Company
JOHNSON & JOHNSON SURGICAL VISION, INC.
Model
93508TRHZ
Catalog number
93508TRHZ
Device description
COMPLETE MPS 2X480ML+LC
Published
2016-09-09
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
20827444000656PackageGS112In Commercial Distribution
00827444000652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2082744400065620827444000656
00827444000652008274440006528274440006520827444000652

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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