FDA.reportPublic FDA data

Biolon

Primary DI
00369918000008
Brand
Biolon
Company
AMRING PHARMACEUTICALS INC.
Model
version 1
Catalog number
62501
Device description
Viscoelastic surgical aid
Published
2018-05-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZPAID, SURGICAL, VISCOELASTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZPAid, Surgical, ViscoelasticOphthalmic3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
01369918000007PackageGS1185Not in Commercial Distribution
00369918000008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01369918000007013699180000071369918000007
00369918000008003699180000083699180000080369918000008

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume1Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not Freeze
Special Storage Condition, Specify00Protect from light
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(443)895-0084muzaffer.mohammed@amringpharma.com
+1(423)252-9924Elizabeth.Rose@iconplc.com

Regulatory Flags#

DUNS number
079843051
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00369918645018Lacrifill Canalicular GelV12024-04-15
00369918645100Lacrifill Canalicular GelV12024-04-15
01369918000007Biolonversion 1625012018-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05050474755093HEALON ENDOCOAT PROJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2025-08-20
05050474755116HEALON DUET PRO IIJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2025-08-20
05050474807433HEALON PROJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2024-04-08
05050474807440HEALON PROJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2024-04-08
05050474807457HEALON GV PROJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2024-04-08
05050474807464HEALON5 PROJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2024-04-08
00763000837211Extended™ Reservoir 3.0mLMEDTRONIC MINIMED, INC.LZP2024-02-17
20763000837215Extended™ Reservoir 3.0mLMEDTRONIC MINIMED, INC.LZP2024-02-17
00763000837235Extended™ ReservoirMEDTRONIC MINIMED, INC.LZP2024-02-12
20763000837239Extended™ ReservoirMEDTRONIC MINIMED, INC.LZP2024-02-12
00763000837259Extended Reservoir™MEDTRONIC MINIMED, INC.LZP2024-02-12
10757770601728StableViscBausch & Lomb IncorporatedLZP2023-04-09
10757770601735TotalViscBausch & Lomb IncorporatedLZP2023-04-09
15060156070373BiolonALTACOR LIMITEDLZP2022-06-07
15060156070380BiolonALTACOR LIMITEDLZP2022-06-07
00817337000128OphthalinAnika Therapeutics, Inc.LZP2021-12-29
00866142000052AnikaviscAnika Therapeutics, Inc.LZP2021-12-29
00757770558360ClearViscBausch & Lomb IncorporatedLZP2021-05-10
05050474651654HEALON GV PROJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2019-05-15
05050474651425HEALON DUET PROJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2018-07-16
05050474636972HEALON PROJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2018-06-25
05050474636989HEALON PROJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2018-06-25
05050474636996HEALON5 PROJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2018-06-25
01369918000007BiolonAMRING PHARMACEUTICALS INC.LZP2018-05-17
00380651999077DUOVISCAlcon Laboratories, Inc.LZP2017-11-14
E314421004000SignatureMaterialise NVLZP2017-07-21
04711605585224UTF Hip StemUNITED ORTHOPEDIC CORP.LZP2017-05-26
00817337000012Precision Lens OphthalmicAnika Therapeutics, Inc.LZP2017-05-18
E31442100400SignatureMaterialise NVLZP2016-09-24
00380651830042PROVISCAlcon Laboratories, Inc.LZP2015-03-31