FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780361619
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
18-120
Catalog number
18-120
Device description
"Integra® Miltex® Jaeger Lid Plate, 4-3/8"", Double-Ended, Blades 21mm and 24mm, 1.25mm Thickness"
Published
2017-06-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNIRetractor, ophthalmic
HOYShield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNIRetractor, OphthalmicOphthalmic1
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780361619PrimaryGS10
H834181201SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178036161910381780361619

GMDN Terms#

Term, Definition table
TermDefinition
Periocular/lacrimal retractor, hand-held, reusableA hand-held, non-self-retaining, ophthalmic surgical instrument intended to be used to separate periocular tissues and/or draw aside the margins of a periocular surgical wound during an ophthalmic intervention (e.g., eyelid retraction, lacrimal sac access). The instrument is typically designed with a shaped/hooked blade or flat plate (e.g., eyelid plate) with a handle/holding portion, and is usually made of metal. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length21Millimeter
Length24Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
081277700
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780024507Integra® Jarit®100539100-5392018-01-22
10381780024514Integra® Jarit®100540100-5402018-01-22
10381780031901Integra® Miltex®27-20227-2022015-09-22
10381780031918Integra® Miltex®27-20427-2042015-09-22
10381780031925Integra® Miltex®27-20627-2062015-09-22
10381780031932Integra® Miltex®27-20827-2082015-09-22
10381780031949Integra® Miltex®27-21027-2102015-09-22
10381780031956Integra® Miltex®27-21227-2122015-09-22
10381780063865Integra® Miltex®4-515C4-515C2018-02-15
10381780063872Integra® Miltex®4-5224-5222018-02-15
10381780063896Integra® Miltex®461146112018-02-15
10381780063902Integra® Miltex®461546152018-02-15
10381780064206Integra® Miltex®33-3833-382018-02-14
10381780128779Integra® Miltex®30-174030-17402016-08-03
10381780133810Integra® Jarit®320437320-4372016-08-12
10381780134503Integra® Jarit®6531016531012018-01-15
10381780136408Integra® Jarit®X37254X372542016-08-14
10381780142874Integra® Jarit®230250230-2502016-08-14
10381780143048Integra® Jarit®320195320-1952016-08-14
10381780143055Integra® Jarit®320196320-1962016-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776420765MillenniumAvalign Technologies, Inc.HNI2026-04-30
00190776420840MillenniumAvalign Technologies, Inc.HNI2026-04-30
00190776420512MillenniumAvalign Technologies, Inc.HNI2026-04-16
16931918105420AllesetGRI Medical & Electronic Technology Co., Ltd.HOY2026-04-10
G22351091I0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNI2026-04-09
10620974004285BetterShieldSouthmedic IncorporatedHOY2025-12-19
10827989003504Health Care Logistics, Inc®Health Care Logistics, Inc.HOY2025-01-08
TQ26126151971Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.HOY2024-12-09
10889483047910SunMed LLCSUNMED, LLCHOY2024-11-11
10887482176815BovieASPEN SURGICAL PRODUCTS, INC.HOY2024-08-26
00194613017101MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2024-08-15
00194613028190MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2024-08-15
00194613030797MSI Precision Specialty InstrumentsMed Saver, Inc.HNI2024-08-15
00194613002770MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2024-04-25
08052276029638Eye Shield AKTIVE SRLHOY2024-01-15
08175700103558Stevenson Lachrymal Sac RetractorAURORA SURGICAL, LLCHNI2024-01-10
08175700103565Knapp Lachrymal Sac Retractor, 4 Blunt ProngsAURORA SURGICAL, LLCHNI2024-01-10
08175700104067Desmarres Lid RetractorAURORA SURGICAL, LLCHNI2024-01-10
08175700104074Desmarres Lid RetractorAURORA SURGICAL, LLCHNI2024-01-10
08175700104081Desmarres Lid RetractorAURORA SURGICAL, LLCHNI2024-01-10
08175700104098Desmarres Lid RetractorAURORA SURGICAL, LLCHNI2024-01-10
08175700104579Schepens Orbital RetractorAURORA SURGICAL, LLCHNI2024-01-10
10810141931043VIVIT SupplyVivit Supply LLCHOY2023-09-15
10810141931050VIVIT SupplyVivit Supply LLCHOY2023-09-15
10810141931067VIVIT SupplyVivit Supply LLCHOY2023-09-15
10810003224443Pro-PaksMICROSPECIALITIES, INC.HOY2023-09-02
10810003224450Pro-PaksMICROSPECIALITIES, INC.HOY2023-09-02
10810003224467Pro-PaksMICROSPECIALITIES, INC.HOY2023-09-02
10810003224474Pro-PaksMICROSPECIALITIES, INC.HOY2023-09-02
16931918188713AllesetGRI Medical & Electronic Technology Co., Ltd.HOY2023-08-07