FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
H8341819901
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
18-1990
Device description
Kerrison Mastoid Rongeur 4", size 0: 3.5mm bite
Published
2017-06-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JZARONGEUR, MASTOID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZARongeur, MastoidEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780362777PrimaryGS10
H8341819901SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178036277710381780362777

GMDN Terms#

Term, Definition table
TermDefinition
Mastoid rongeurA surgical instrument designed to remove hard or tough tissues (e.g., bone or cartilage) around the mastoid process (the large projection of the temporal bone of the skull found immediately behind each ear) by applying a biting/cutting action during ear/nose/throat (ENT) surgery. It is has a forceps or pliers-like design terminating at the distal end with sharp-edged, scoop-shaped, narrow jaws attached to strong, sprung (self-opening), pivoted handles that, when squeezed together, close the jaws to bite (cut) through the mastoid tissue. It is available in various sizes and is made of high-grade stainless steel and designed to withstand the forces which are applied. 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
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780024507Integra® Jarit®100539100-5392018-01-22
10381780024514Integra® Jarit®100540100-5402018-01-22
10381780031901Integra® Miltex®27-20227-2022015-09-22
10381780031918Integra® Miltex®27-20427-2042015-09-22
10381780031925Integra® Miltex®27-20627-2062015-09-22
10381780031932Integra® Miltex®27-20827-2082015-09-22
10381780031949Integra® Miltex®27-21027-2102015-09-22
10381780031956Integra® Miltex®27-21227-2122015-09-22
10381780063865Integra® Miltex®4-515C4-515C2018-02-15
10381780063872Integra® Miltex®4-5224-5222018-02-15
10381780063896Integra® Miltex®461146112018-02-15
10381780063902Integra® Miltex®461546152018-02-15
10381780064206Integra® Miltex®33-3833-382018-02-14
10381780128779Integra® Miltex®30-174030-17402016-08-03
10381780133810Integra® Jarit®320437320-4372016-08-12
10381780134503Integra® Jarit®6531016531012018-01-15
10381780136408Integra® Jarit®X37254X372542016-08-14
10381780142874Integra® Jarit®230250230-2502016-08-14
10381780143048Integra® Jarit®320195320-1952016-08-14
10381780143055Integra® Jarit®320196320-1962016-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613114886MSI Precision Specialty InstrumentsMed Saver, Inc.JZA2025-08-01
00190776383602MillenniumAvalign Technologies, Inc.JZA2024-08-20
00190776306991MillenniumAvalign Technologies, Inc.JZA2023-11-16
00190776296902MillenniumAvalign Technologies, Inc.JZA2022-12-12
04046826105389MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZA2020-09-24
04046826105396MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZA2020-09-24
04046826105402MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZA2020-09-24
04046826105419MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZA2020-09-24
10381780083245Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-10-24
00888118059284RONGEURKLS-Martin L.P.JZA2018-09-26
00888118059291RONGEURKLS-Martin L.P.JZA2018-09-26
00888118059307RONGEURKLS-Martin L.P.JZA2018-09-26
00888118059314RONGEURKLS-Martin L.P.JZA2018-09-26
00888118057952RONGEURKLS-Martin L.P.JZA2018-09-26
00888118057969RONGEURKLS-Martin L.P.JZA2018-09-26
00888118057976RONGEURKLS-Martin L.P.JZA2018-09-26
10381780076810Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-09-17
10381780076827Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-09-17
10381780076834Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-09-17
10381780076841Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-09-17
10381780198154Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-03-27
M2743803051Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-03-27
10381780445326Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05
10381780445333Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05
10381780445418Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05
10381780445425Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05
10381780445432Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05
10381780445449Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05
H834MH1912300Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05
H834MH1912320Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05