FDA.reportPublic FDA data

Integra®

Primary DI
10381780080473
Brand
Integra®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
3714600
Catalog number
3714600
Device description
Integra® Frontal Ostium Seeker
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
KAKPROBE, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAKProbe, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780080473PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178008047310381780080473

GMDN Terms#

Term, Definition table
TermDefinition
Paranasal sinus probeA hand-held manual surgical instrument designed for introduction into the air cavities in the cranial bones which communicate with the nasal cavity (i.e., paranasal sinuses) to explore and/or dilate strictures in the passages from the nose to the communicating sinuses, typically during ear/nose/throat (ENT) surgery. 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
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
09348811115829INKAThe Trustee for KAISER FAMILY TRUSTKAK2026-04-24
09348811005106INKAThe Trustee for KAISER FAMILY TRUSTKAK2026-03-18
00714646001535Lighted Magnetic Foreign Body Removal ToolBionix, LLCKAK2026-03-03
10714646001532Lighted Magnetic Foreign Body Removal ToolBionix, LLCKAK2026-03-03
00714646001627Lighted Magnetic Foreign Body Removal ToolBionix, LLCKAK2026-03-03
09348811115836INKAThe Trustee for KAISER FAMILY TRUSTKAK2025-11-25
09348811112149INKAThe Trustee for KAISER FAMILY TRUSTKAK2025-11-21
09348811150448INKAThe Trustee for KAISER FAMILY TRUSTKAK2025-11-21
04250676728609Tube probeSpiggle & Theis Medizintechnik GmbHKAK2025-10-10
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04250676731999Salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
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04250676732026Salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676732033Salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740625Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740632Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740649Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740656Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740663Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740687Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740694Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740700Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740717Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
00190776409487MillenniumAvalign Technologies, Inc.KAK2025-09-02
00757770407972Bausch + LombBausch & Lomb IncorporatedKAK2025-08-05
00757770636334Bausch + LombBausch & Lomb IncorporatedKAK2025-08-05
00194613044404MSI Precision Specialty InstrumentsMed Saver, Inc.KAK2025-08-01
00194613048952MSI Precision Specialty InstrumentsMed Saver, Inc.KAK2025-08-01
00194613059804MSI Precision Specialty InstrumentsMed Saver, Inc.KAK2025-08-01
00194613102227MSI Precision Specialty InstrumentsMed Saver, Inc.KAK2025-08-01