FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780421856
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
20-378
Catalog number
20-378
Device description
Integra® Miltex® Wiener Antrum Rasp, No. 1, Small, Trocar Tip
Published
2018-01-12
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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780421856PrimaryGS10
H834203780SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178042185610381780421856

GMDN Terms#

Term, Definition table
TermDefinition
Frontal sinus file/raspA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth at the distal working end designed to scrape, clean out, and enlarge the frontal sinus cavities during ear/nose/throat (ENT) surgery. It is available in two main designs: 1) a one-piece instrument that has circular cutting ridges at the tip of the curved distal working end and a handle at the proximal end; or 2) a tubular construction that allows for integrated suction (a tube from a suction system is connected to its proximal end) and a rasp (e.g., diamond coating) at the contoured working end. It is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Width3Millimeter

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
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
00885556869017Kompressor Compression Screw SystemSmith & Nephew, Inc.KAZ2022-12-22
10381780080190Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-09-17
10381780080206Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-09-17
24026704505801PILLINGTELEFLEX INCORPORATEDKAZ2018-09-15
24026704506679PILLINGTELEFLEX INCORPORATEDKAZ2018-09-15
24026704527049PILLINGTELEFLEX INCORPORATEDKAZ2018-09-15
10381780190950Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-04-02
10381780190967Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-04-02
10381780190974Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-04-02
10381780190981Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-04-02
M2744002341Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-04-02
M2744002351Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-04-02
M2744002361Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-04-02
M2744002371Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-04-02
10381780421863Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-01-12
10381780421870Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-01-12
H834203780Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-01-12
H834203800Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-01-12
H834203820Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-01-12
00849233014589Busse Hospital DisposablesROBERT BUSSE & CO., INC.KAZ2016-09-14