FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780468134
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
19-322
Catalog number
19-322
Device description
Integra® Miltex® Ear Curette, Disposable, Small Spoon Tip, Gray, Box of 50, Non-Sterile
Published
2018-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
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
10381780468134PrimaryGS10
H834193221SecondaryHIBCC0
00381780468137Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038178046813410381780468134
00381780468137003817804681373817804681370381780468137

GMDN Terms#

Term, Definition table
TermDefinition
Ear canal irrigation kit, single-useA collection of items intended to be used to flush cerumen (ear wax) out of the ear canal during an ear/nose/throat (ENT) procedure. It consists of a manual syringe and other accessory items. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
081277700
Device count
50
Premarket exempt
true
Lot or batch
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
04250676750846Buck ear curetteSpiggle & Theis Medizintechnik GmbHJYG2026-10-28
04250676750853Buck ear curetteSpiggle & Theis Medizintechnik GmbHJYG2026-10-28
04250676750860Buck ear curetteSpiggle & Theis Medizintechnik GmbHJYG2026-10-28
04250676750877Buck ear curetteSpiggle & Theis Medizintechnik GmbHJYG2026-10-28
04250676750884Buck ear curetteSpiggle & Theis Medizintechnik GmbHJYG2026-10-28
04250676751164Shapleigh ear curetteSpiggle & Theis Medizintechnik GmbHJYG2026-10-28
04250676751171Shapleigh ear curetteSpiggle & Theis Medizintechnik GmbHJYG2026-10-28
04250676751201Buck ear curetteSpiggle & Theis Medizintechnik GmbHJYG2026-10-28
04250676751218Buck ear curetteSpiggle & Theis Medizintechnik GmbHJYG2026-10-28
04250676751225Buck ear curetteSpiggle & Theis Medizintechnik GmbHJYG2026-10-28
04250676751232Buck ear curetteSpiggle & Theis Medizintechnik GmbHJYG2026-10-28
04250676751249Buck ear curetteSpiggle & Theis Medizintechnik GmbHJYG2026-10-28
00724995274092V. MuellerSTERIS Deutschland GmbHJYG2026-10-21
00190776434304MillenniumAvalign Technologies, Inc.JYG2026-10-06
00724995271244V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
00724995271251V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
00724995271268V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
00724995271275V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
00724995271626V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
00724995271633V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
00724995271640V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
00724995271657V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
00724995271800V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
00724995273958V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
00724995273965V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
04054462901630evonosevonos GmbH & Co. KGJYG2026-08-21
04054462901647evonosevonos GmbH & Co. KGJYG2026-08-21
04054462901654evonosevonos GmbH & Co. KGJYG2026-08-21
04054462901661evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908134evonosevonos GmbH & Co. KGJYG2026-08-21