FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
H834193231
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
19-323
Catalog number
19-323
Device description
Ear Curette, Disposable, Large Spoon Tip, Peach, 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
Rx
false
OTC
true
Sterile
false
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
10381780468141PrimaryGS10
H834193231SecondaryHIBCC0
00381780468144Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038178046814110381780468141
00381780468144003817804681443817804681440381780468144

GMDN Terms#

Term, Definition table
TermDefinition
Ear 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
081277700
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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