FDA.reportPublic FDA data

Integra®

Primary DI
10381780080190
Brand
Integra®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
3714401
Catalog number
3714401
Device description
Integra® Wiener Antrum Rasp, Large Trocar Tip
Published
2018-09-17
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
KAZRASP, FRONTAL-SINUS
KBARASP, NASAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAZRasp, Frontal-SinusEar, Nose, Throat1
KBARasp, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780080190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178008019010381780080190

GMDN Terms#

Term, Definition table
TermDefinition
Nasal file/raspA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth at the working end(s) designed to remove and profile the cartilage/bone of the nose during ear/nose/throat (ENT) or plastic surgery. It is typically a one-piece instrument available in a variety of sizes and working end designs, including straight and curved ends, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
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
00190776424039MillenniumAvalign Technologies, Inc.KBA2026-08-27
09348811103291INKAThe Trustee for KAISER FAMILY TRUSTKBA2026-07-31
00190776400491MillenniumAvalign Technologies, Inc.KBA2026-07-17
00810220800256Adler Instrument CompanyAdler, Inc.KBA2026-05-26
00190776420147MillenniumAvalign Technologies, Inc.KBA2026-04-16
00190776420154MillenniumAvalign Technologies, Inc.KBA2026-04-16
00190776420161MillenniumAvalign Technologies, Inc.KBA2026-04-16
14026704941688PILLINGTELEFLEX INCORPORATEDKBA2026-02-11
24026704941685PILLINGTELEFLEX INCORPORATEDKBA2026-02-11
09348811102744INKAThe Trustee for KAISER FAMILY TRUSTKBA2025-11-28
09348811103246INKAThe Trustee for KAISER FAMILY TRUSTKBA2025-11-28
09348811103253INKAThe Trustee for KAISER FAMILY TRUSTKBA2025-11-28
09348811103260INKAThe Trustee for KAISER FAMILY TRUSTKBA2025-11-28
G043662100BEARBear-Ent, LLCKBA2025-10-08
04250676732187Nasal raspSpiggle & Theis Medizintechnik GmbHKBA2025-09-25
04250676732194Nasal raspSpiggle & Theis Medizintechnik GmbHKBA2025-09-25
04250676740229Joseph nasal raspSpiggle & Theis Medizintechnik GmbHKBA2025-09-19
04250676740236Joseph nasal raspSpiggle & Theis Medizintechnik GmbHKBA2025-09-19
00190776409920MillenniumAvalign Technologies, Inc.KBA2025-09-08
00194613032586MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613032616MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613032623MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613032647MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613032661MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613032685MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613047887MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613110314MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613110321MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613111236MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613116941MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01