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
10381780406914Integra® Jarit®X312143X3121432018-05-03
10381780421245Integra® Miltex®20-103220-10322017-12-21
10381780076155Integra®371106837110682018-09-17
10381780076162Integra®371106937110692018-09-17
10381780076179Integra®371107137110712018-09-17
10381780533276Codman®901001BRKT901001BRKT2026-10-15
10381780533283Codman®901001POLC901001POLC2026-10-15
10381780129103Integra® Jarit®615296B615-296B2016-08-11
10381780146025Integra® Jarit®600CTVA600-CTVA2016-08-24
10381780146032Integra® Jarit®600SCR138600-SCR-1382016-08-24
10381780146049Integra® Jarit®600SPR138600-SPR-1382016-08-24
10381780146056Integra® Jarit®600SPS550600-SPS-5502016-08-24
10381780146698Integra® Jarit®610107DA610-107DA2016-08-24
10381780147053Integra® Jarit®625107RD625-107RD2016-08-24
10381780147404Integra® Jarit®630107IL630-107IL2016-08-24
10381780147541Integra® Jarit®632107IL632-107IL2016-08-24
10381780152866Integra® Ruggles®-Redmond™R6312R63122016-08-11
10381780152873Integra® Ruggles®-Redmond™R8974R89742016-08-11
10381780152880Integra® Ruggles®-Redmond™R8978R89782016-08-11
10381780154495Integra® Ruggles®-Redmond™R2381R23812016-08-11

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995317607V. MuellerSTERIS Deutschland GmbHHNI2026-10-15
00724995317638V. MuellerSTERIS Deutschland GmbHHNI2026-10-15
00724995317645V. MuellerSTERIS Deutschland GmbHHNI2026-10-15
00724995317652V. MuellerSTERIS Deutschland GmbHHNI2026-10-15
00190776436520MilleniumAvalign Technologies, Inc.HNI2026-10-08
00724995318178V. MuellerSTERIS Deutschland GmbHHNI2026-09-25
10840113242426BovieASPEN SURGICAL PRODUCTS, INC.HOY2026-08-17
B382SD1553000Surgical DirectSurgical Direct, Inc.HNI2026-07-31
00190776403799MillenniumAvalign Technologies, Inc.HNI2026-07-21
00190776403805MillenniumAvalign Technologies, Inc.HNI2026-07-21
00827989008137SAFEVIEWHealth Care Logistics, Inc.HOY2026-07-10
00860009651647KC Eye Tape - 50 PairsKelCor, LLCHOY2026-07-10
00840456222867JMUJMU DENTAL, INCHOY2026-07-07
00840456222874JMUJMU DENTAL, INCHOY2026-07-07
D125720C4Premium PlusPremium Plus (Dongguan) LimitedHOY2026-06-09
D125720CR4Premium PlusPremium Plus (Dongguan) LimitedHOY2026-06-09
D125720T4Premium PlusPremium Plus (Dongguan) LimitedHOY2026-06-09
D125720TR4Premium PlusPremium Plus (Dongguan) LimitedHOY2026-06-09
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
10889483047910SunMed LLCSUNMED, LLCHOY2024-11-11
10887482176815BovieASPEN SURGICAL PRODUCTS, INC.HOY2024-08-26
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