FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780363088
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
18-380
Catalog number
18-380
Device description
"Integra® Miltex® Ellis Foreign Body Spud, 4-1/2"", 1.2mm blade, curved"
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
HNASpud, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNASpud, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780363088PrimaryGS10
H834183801SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178036308810381780363088

Device Sizes#

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

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
10381780541585CODMAN® ACCU-FLO®82620282-62022024-05-29
10381780541738CODMAN®82304882-30482024-05-29
10381780536918CODMAN® ACCU-FLO®82152082-15202024-05-29
10381780536925CODMAN® ACCU-FLO®82152182-15212024-05-29
10381780537373CODMAN®82409582-40952024-05-29
10381780537380CODMAN®82859182-85912024-05-29
10381780541578CODMAN® ACCU-FLO®82620182-62012024-05-29
10381780541745CODMAN®82304982-30492024-05-29
10381780090977Integra®961020096102002018-10-26
10381780075073Integra®165002516500252018-09-17
10381780075080Integra®165003016500302018-09-17
10381780075097Integra®165005016500502018-09-17
10381780518525CODMAN® HAKIM®82300782-30072020-06-02
10381780518532CODMAN® HAKIM®82300882-30082020-06-02
10381780518600CODMAN® HAKIM®82301582-30152020-06-02
10381780518716CODMAN® HAKIM®82302682-30262020-06-02
10381780518761CODMAN® HAKIM®82303582-30352020-06-02
10381780518808CODMAN® HAKIM®82303982-30392020-06-02
10381780518976CODMAN® HAKIM®82308282-30822020-06-02
10381780519010CODMAN® HAKIM®82308682-30862020-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015282057Intrace USAPILOTIS TECH LLCHNA2026-07-03
04251047903090Rosen Phaco SplitterA1 Medical GmbHHNA2026-06-09
04251047903274Lester IOL-ManipulatorA1 Medical GmbHHNA2026-06-09
04251047913549Bechert Nucleus RotatorA1 Medical GmbHHNA2026-06-09
04251047928604Drysdale Nucleus ManipulatorA1 Medical GmbHHNA2026-06-09
05056111322123SurtexSURTEX INSTRUMENTS LTD.HNA2026-05-12
00041533986539Bruder KarpeckiThe Hilsinger Company Parent, LlcHNA2026-02-25
00041533996538Bruder KarpeckiThe Hilsinger Company Parent, LlcHNA2026-02-25
00194613004521MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613005344MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613005351MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613005368MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613030643MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613091859MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613121792MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613121969MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
G412PH60920MR PHACOCrestpoint Management LimitedHNA2025-06-07
G412PH60930MR PHACOCrestpoint Management LimitedHNA2025-06-07
00194613005337MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-03-21
00194613005375MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-03-21
00194613021139MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-03-21
00194613039899MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-03-21
00194613053932MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-03-21
00757770408993Bausch + LombBausch & Lomb IncorporatedHNA2024-11-21
00757770414284Bausch + LombBausch & Lomb IncorporatedHNA2024-11-21
00757770418893Bausch + LombBausch & Lomb IncorporatedHNA2024-11-21
00887482108628Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.HNA2024-08-20
G586OP7125400Novo SurgicalNOVO SURGICAL, INC.HNA2023-12-18
G586OP7125540Novo SurgicalNOVO SURGICAL, INC.HNA2023-12-18
00190776355371MillenniumAvalign Technologies, Inc.HNA2023-11-17