FDA.reportPublic FDA data

Integra®

Primary DI
10381780082064
Brand
Integra®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
3722087
Catalog number
3722087
Device description
McCabe Perforation Rasp
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
10381780082064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178008206410381780082064

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
Device Size Text, specify0
Device Size Text, specify0

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
10381780406914Integra® Jarit®X312143X3121432018-05-03
10381780421245Integra® Miltex®20-103220-10322017-12-21
10381780076155Integra®371106837110682018-09-17
10381780076162Integra®371106937110692018-09-17
10381780076179Integra®371107137110712018-09-17
10381780533276Codman®901001BRKT901001BRKT2026-10-15
10381780533283Codman®901001POLC901001POLC2026-10-15
10381780129103Integra® Jarit®615296B615-296B2016-08-11
10381780146025Integra® Jarit®600CTVA600-CTVA2016-08-24
10381780146032Integra® Jarit®600SCR138600-SCR-1382016-08-24
10381780146049Integra® Jarit®600SPR138600-SPR-1382016-08-24
10381780146056Integra® Jarit®600SPS550600-SPS-5502016-08-24
10381780146698Integra® Jarit®610107DA610-107DA2016-08-24
10381780147053Integra® Jarit®625107RD625-107RD2016-08-24
10381780147404Integra® Jarit®630107IL630-107IL2016-08-24
10381780147541Integra® Jarit®632107IL632-107IL2016-08-24
10381780152866Integra® Ruggles®-Redmond™R6312R63122016-08-11
10381780152873Integra® Ruggles®-Redmond™R8974R89742016-08-11
10381780152880Integra® Ruggles®-Redmond™R8978R89782016-08-11
10381780154495Integra® Ruggles®-Redmond™R2381R23812016-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776423926MillenniumAvalign Technologies, Inc.JYY2026-08-27
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09348811112804INKAThe Trustee for KAISER FAMILY TRUSTJYY2025-11-24
00757770420384Bausch + LombBausch & Lomb IncorporatedJYY2025-08-05
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
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00840319742655Hayden MedicalHayden Medical, Inc.JYY2023-03-14
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14026704807762PILLINGTELEFLEX INCORPORATEDJYY2022-12-08
14026704807779PILLINGTELEFLEX INCORPORATEDJYY2022-12-08