FDA.reportPublic FDA data

HEALON ENDOCOAT PRO

Primary DI
05050474755093
Brand
HEALON ENDOCOAT PRO
Company
JOHNSON & JOHNSON SURGICAL VISION, INC.
Model
10300012
Catalog number
10300012
Device description
HEALON ENDOCOAT PRO 0,85 ML USA
Published
2025-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
05050474755093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05050474755093050504747550935050474755093

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00DO NOT FREEZE
Special Storage Condition, Specify00KEEP AWAY FROM SUNLIGHT
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
103021940
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05050474806153PURESEE IOLDEN00VDEN00VU0502026-03-16
05050474806160PURESEE IOLDEN00VDEN00VU0552026-03-16
05050474806177PURESEE IOLDEN00VDEN00VU0602026-03-16
05050474806184PURESEE IOLDEN00VDEN00VU0652026-03-16
05050474806191PURESEE IOLDEN00VDEN00VU0702026-03-16
05050474806207PURESEE IOLDEN00VDEN00VU0752026-03-16
05050474806214PURESEE IOLDEN00VDEN00VU0802026-03-16
05050474806221PURESEE IOLDEN00VDEN00VU0852026-03-16
05050474806238PURESEE IOLDEN00VDEN00VU0902026-03-16
05050474806245PURESEE IOLDEN00VDEN00VU0952026-03-16
05050474806252PURESEE IOLDEN00VDEN00VU1002026-03-16
05050474806269PURESEE IOLDEN00VDEN00VU1052026-03-16
05050474806276PURESEE IOLDEN00VDEN00VU1102026-03-16
05050474806283PURESEE IOLDEN00VDEN00VU1152026-03-16
05050474806290PURESEE IOLDEN00VDEN00VU1202026-03-16
05050474806306PURESEE IOLDEN00VDEN00VU1252026-03-16
05050474806313PURESEE IOLDEN00VDEN00VU1302026-03-16
05050474806320PURESEE IOLDEN00VDEN00VU1352026-03-16
05050474806337PURESEE IOLDEN00VDEN00VU1402026-03-16
05050474806344PURESEE IOLDEN00VDEN00VU1452026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00369918000008BiolonAMRING PHARMACEUTICALS INC.LZP2018-05-17
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