FDA.reportPublic FDA data

Integra®

Primary DI
10381780082125
Brand
Integra®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
3722093
Catalog number
3722093
Device description
Integra® McGee Oval Window Rasp, Large, 0.7mm Diameter
Published
2018-10-24
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
JYYRASP, EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYYRasp, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780082125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178008212510381780082125

GMDN Terms#

Term, Definition table
TermDefinition
Middle ear 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 and smooth the bony structures of the middle ear. It is typically used during ear/nose/throat (ENT) or plastic surgery; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle15degree
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter0.7Millimeter

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
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00757770404384Bausch + LombBausch & Lomb IncorporatedJYY2025-08-04
00757770422722Bausch + LombBausch & Lomb IncorporatedJYY2025-08-04
00757770435647Bausch + LombBausch & Lomb IncorporatedJYY2025-08-04
00887482035160Symmetry WienerASPEN SURGICAL PRODUCTS, INC.JYY2024-08-12
00887482120057Symmetry WienerASPEN SURGICAL PRODUCTS, INC.JYY2024-08-12
00840183525958BR Surgical, LLCBR Surgical, LLCJYY2024-06-03
G586E7773430Novo SurgicalNOVO SURGICAL, INC.JYY2023-12-18
G586E7773450Novo SurgicalNOVO SURGICAL, INC.JYY2023-12-18
00190776324308MillenniumAvalign Technologies, Inc.JYY2023-11-13
00190776324346MillenniumAvalign Technologies, Inc.JYY2023-11-13
00190776324292MILLENNIUMAvalign Technologies, Inc.JYY2023-09-28
00190776324339MILLENNIUMAvalign Technologies, Inc.JYY2023-09-28
00190776376529AvalignAvalign Technologies, Inc.JYY2023-09-28
00810123201525Adler Instrument CompanyAdler, Inc.JYY2023-03-15
00840319742624Hayden MedicalHayden Medical, Inc.JYY2023-03-14
00840319742631Hayden MedicalHayden Medical, Inc.JYY2023-03-14
00840319742648Hayden MedicalHayden Medical, Inc.JYY2023-03-14
00840319742655Hayden MedicalHayden Medical, Inc.JYY2023-03-14
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