FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780363125
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
18-398
Catalog number
18-398
Device description
Integra® Miltex® Magnetic Eye Probel, With Foreign Body Loop
Published
2018-09-12
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
HPNMagnet, permanent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HPNMagnet, PermanentOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780363125PrimaryGS10
H834183980SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178036312510381780363125

GMDN Terms#

Term, Definition table
TermDefinition
Eye magnet, non-poweredA non-electric hand-held instrument designed to generate a magnetic field intended to locate and remove metallic foreign bodies [typically those containing iron (Fe) or steel] from eye tissue; it may include a wire loop at one end for mechanical extraction. This is a reusable device.

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
10381780156802Integra® Ruggles®-Redmond™RN2528RN25282016-08-14
10381780167075Integra® Jarit®500105500-1052018-04-09
10381780394761Integra® Jarit®500100500-1002018-04-09
10381780394778Integra® Jarit®500110500-1102018-04-09
10381780394808Integra® Jarit®500135500-1352018-04-09
10381780435860Integra® Miltex®30-3030-302018-01-24
10381780435907Integra® Miltex®30-5530-552018-01-24
10381780435952Integra® Miltex®30-6230-622018-01-24
10381780488248Integra® Miltex®MH30-10MH30-102018-08-20
10381780488262Integra® Miltex®MH30-15MH30-152018-08-20
10381780488279Integra® Miltex®MH30-20MH30-202018-08-20
10381780488286Integra® Miltex®MH30-30MH30-302018-08-20
10381780488293Integra® Miltex®MH30-50MH30-502018-08-20
10381780488361Integra® Miltex®MH30-55MH30-552018-08-20
10381780488378Integra® Miltex®MH30-60MH30-602018-08-20
10381780488385Integra® Miltex®MH30-62MH30-622018-08-20
10381780500490Integra® Miltex®30-1030-102018-09-18
10381780500520Integra® Miltex®30-1530-152018-09-18
10381780500605Integra® Miltex®30-2030-202018-09-18
10381780077244Integra®371231037123102018-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00041533986584BruderThe Hilsinger Company Parent, LlcHPN2026-02-25
10842209131515NARNORTH AMERICAN RESCUE, LLCHPN2024-06-10
00842209131518NARNORTH AMERICAN RESCUE, LLCHPN2024-06-10
14897076721655Multi.D.1.5TENS PLUS INDUSTRIAL COMPANYHPN2023-06-05
14897076722577Bio.N.2TENS PLUS INDUSTRIAL COMPANYHPN2023-06-05
04049368118312N.A.Geuder AktiengesellschaftHPN2021-02-23
04046826097875MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHPN2020-09-25
00850013958122Wizard WandC F M TECHNOLOGIES INCHPN2020-01-06
00850013958139CFM TechnologiesC F M TECHNOLOGIES INCHPN2020-01-06
00850013958146CFM TechnologiesC F M TECHNOLOGIES INCHPN2020-01-06
00850013958245CFM TechnologiesC F M TECHNOLOGIES INCHPN2020-01-06
00850013958252CFM TechnologiesC F M TECHNOLOGIES INCHPN2020-01-06
H834183980Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHPN2018-09-12
10381780195306Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHPN2018-04-09
M2743503301Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHPN2018-04-09