FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
H834MH198480
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
MH19-848
Catalog number
MH19-848
Device description
Ruskin Rongeur 5-7/8", Straight, 3.5mm Bite
Published
2018-02-05
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
10381780445425PrimaryGS10
H834MH198480SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178044542510381780445425

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial rongeur, reusableA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (cartilage, sinew) or bone, through a cutting/biting action, during surgery involving the cranium and/or face (e.g., craniotomy, ethmoidectomy, mastoidectomy, rhinoplasty); it is not dedicated to dental surgery. It is typically made of metal and designed to withstand the forces required to bite over tough/hard tissue. 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
10381780544319Codman® CereLink®826820P826820P2025-03-12
10381780524106CODMAN® BACTISEAL®NS0344NS03442024-11-20
10381780525370CODMAN® BACTISEAL®NS5091NS50912024-11-20
10381780521280CODMAN® CERTAS® Plus828807PL82-8807PL2024-11-20
10381780535805CODMAN® CERTAS® Plus828813PL82-8813PL2024-11-20
10381780535843CODMAN® CERTAS® Plus828823PL82-8823PL2024-11-20
10381780535867CODMAN® CERTAS® Plus828827PL82-8827PL2024-11-20
10381780536970CODMAN® BACTISEAL®82174582-17452024-11-20
10381780536987CODMAN® BACTISEAL®82307282-30722024-11-20
10381780536994CODMAN® BACTISEAL®82307382-30732024-11-20
10381780537007CODMAN® BACTISEAL®82307482-30742024-11-20
10381780537014CODMAN® BACTISEAL®82174982-17492024-11-20
10381780537021CODMAN® BACTISEAL®82175082-17502024-11-20
10381780537038CODMAN® BACTISEAL®82308782-30872024-11-20
10381780537045CODMAN® BACTISEAL®82308882-30882024-11-20
10381780537052CODMAN® BACTISEAL®NS0338NS03382024-11-20
10381780537069CODMAN® BACTISEAL®NS0339NS03392024-11-20
10381780537076CODMAN® BACTISEAL®NS0340NS03402024-11-20
10381780537083CODMAN® BACTISEAL®NS0343NS03432024-11-20
10381780537090CODMAN® HAKIM® BACTISEAL®NS5048NS50482024-11-20

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
M2743803051Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-03-27
H834MH1912300Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05
H834MH1912320Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05
H834MH198440Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05
H834MH198500Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05
H834MH198520Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05
H834MH198490Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-01-24
H8341912300Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2017-12-21
H8341912320Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2017-12-21
H8341912340Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2017-12-21