FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780419631
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
19-290
Catalog number
19-290
Device description
Integra® Miltex® Buck Ear Curette, Angled, Blunt, Size 00
Published
2017-12-21
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
JYGCURETTE, EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYGCurette, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780419631PrimaryGS10
H834192900SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178041963110381780419631

GMDN Terms#

Term, Definition table
TermDefinition
Salpingeal curetteA slender, hand-held, surgical instrument that is used to clear blockages of the Eustachian tube during an ear/nose/throat (ENT) procedure. It is typically made of high-grade stainless steel and can be either rigid or malleable (bendable) and has a small, half-rounded, head terminating in a sharp scraping edge at its widest diameter at the curved distal end of a long shaft which has a handle at the proximal end. The scraping tip is available in various shapes and sizes. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Outer Diameter2.2Millimeter

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
10381780191070Integra® Jarit®400293400-2932018-04-02
10381780193180Integra® Jarit®P408P4082018-04-02
10381780197997Integra® Jarit®380232380-2322017-09-29
10381780198000Integra® Jarit®380233380-2332018-03-22
10381780198543Integra® Jarit®385295385-2952018-03-22
10381780220121Integra® Jarit®P666P6662018-01-31
10381780390381Integra® Jarit®380230380-2302018-02-16
10381780390398Integra® Jarit®380231380-2312018-02-16
10381780456469Integra® Jarit®405225405-2252018-01-31
10381780457190Integra® Jarit®P667P6672018-01-31
10381780458159Integra® Jarit®385315385-3152018-03-01
10381780458166Integra® Jarit®385316385-3162018-03-01
10381780487708Integra® Miltex®MH21-300MH21-3002018-08-22
10381780503910Integra® Miltex®PM-666PM-6662020-10-01
10381780520665CereLink™82684582-68452020-04-01
10381780087984Integra®375001237500122018-10-26
10381780081371Integra®372201137220112018-10-24
10381780081388Integra®372201237220122018-10-24
10381780081906Integra®372206937220692018-10-24
10381780081913Integra®372207037220702018-10-24

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Primary DI, Brand, Company table
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04054462908134evonosevonos GmbH & Co. KGJYG2026-08-21
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04054462908158evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908165evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908172evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908189evonosevonos GmbH & Co. KGJYG2026-08-21
04054462901678evonosevonos GmbH & Co. KGJYG2026-08-18
04054462901685evonosevonos GmbH & Co. KGJYG2026-08-18
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