FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780361183
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
174800
Catalog number
17-4800
Device description
"Integra® Miltex® Friedman Microsurgery Rongeur, 5-1/2"", Straight, Jaw Width 1.3mm"
Published
2017-06-28
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
KBBRONGEUR, NASAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBBRongeur, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780361183PrimaryGS10
H8341748001SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178036118310381780361183

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.

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780156802Integra® Ruggles®-Redmond™RN2528RN25282016-08-14
10381780167075Integra® Jarit®500105500-1052018-04-09
10381780394761Integra® Jarit®500100500-1002018-04-09
10381780394778Integra® Jarit®500110500-1102018-04-09
10381780394808Integra® Jarit®500135500-1352018-04-09
10381780435860Integra® Miltex®30-3030-302018-01-24
10381780435907Integra® Miltex®30-5530-552018-01-24
10381780435952Integra® Miltex®30-6230-622018-01-24
10381780488248Integra® Miltex®MH30-10MH30-102018-08-20
10381780488262Integra® Miltex®MH30-15MH30-152018-08-20
10381780488279Integra® Miltex®MH30-20MH30-202018-08-20
10381780488286Integra® Miltex®MH30-30MH30-302018-08-20
10381780488293Integra® Miltex®MH30-50MH30-502018-08-20
10381780488361Integra® Miltex®MH30-55MH30-552018-08-20
10381780488378Integra® Miltex®MH30-60MH30-602018-08-20
10381780488385Integra® Miltex®MH30-62MH30-622018-08-20
10381780500490Integra® Miltex®30-1030-102018-09-18
10381780500520Integra® Miltex®30-1530-152018-09-18
10381780500605Integra® Miltex®30-2030-202018-09-18
10381780077244Integra®371231037123102018-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04054462910960evonosevonos GmbH & Co. KGKBB2026-08-19
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04054462911028evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911035evonosevonos GmbH & Co. KGKBB2026-08-19
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04054462911066evonosevonos GmbH & Co. KGKBB2026-08-19
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04054462911080evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911097evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911103evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911110evonosevonos GmbH & Co. KGKBB2026-08-19
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04054462911134evonosevonos GmbH & Co. KGKBB2026-08-19
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04054462911165evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911172evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911189evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911196evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911202evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911219evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911226evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911233evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911257evonosevonos GmbH & Co. KGKBB2026-08-19