FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
10381780199892
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
430108
Catalog number
430-108
Device description
Integra® Jarit® La Force Adenotome Blade for REF# 430-103, 16mm Wide, Size 2, Medium
Published
2018-03-02
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
KBHADENOTOME

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBHAdenotomeEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780199892PrimaryGS10
M2744301081SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178019989210381780199892

GMDN Terms#

Term, Definition table
TermDefinition
AdenotomeA hand-held manual surgical instrument designed to excise hypertrophic lymphoid tissue in the nasopharynx (i.e., pharyngeal tonsils or adenoids) during a procedure known as an adenoidectomy. It is typically a long, slender instrument with cutting blades at the working end, and a handle with a mechanism to operate the blades. It is available in various designs and sizes and may be a one-piece instrument or require the insertion of the blades into the handle. 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
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
00757770420322Bausch + LombBausch & Lomb IncorporatedKBH2025-07-29
00757770424443Bausch + LombBausch & Lomb IncorporatedKBH2025-07-29
00757770429974Bausch + LombBausch & Lomb IncorporatedKBH2025-07-29
00757770430055Bausch + LombBausch & Lomb IncorporatedKBH2025-07-29
00190776381943MillenniumAvalign Technologies, Inc.KBH2024-04-30
G586E8221210Novo SurgicalNOVO SURGICAL, INC.KBH2023-12-18
G586E8221220Novo SurgicalNOVO SURGICAL, INC.KBH2023-12-18
G586E8221230Novo SurgicalNOVO SURGICAL, INC.KBH2023-12-18
G586E8221240Novo SurgicalNOVO SURGICAL, INC.KBH2023-12-18
G586E8221720Novo SurgicalNOVO SURGICAL, INC.KBH2023-12-18
G586E8221730Novo SurgicalNOVO SURGICAL, INC.KBH2023-12-18
G586E8221740Novo SurgicalNOVO SURGICAL, INC.KBH2023-12-18
00190776352721MillenniumAvalign Technologies, Inc.KBH2023-11-17
00190776049430AvalignAvalign Technologies, Inc.KBH2023-09-28
00190776227999AvalignAvalign Technologies, Inc.KBH2023-09-28
00190776228002AvalignAvalign Technologies, Inc.KBH2023-09-28
00190776228019AvalignAvalign Technologies, Inc.KBH2023-09-28
00190776327194MillenniumAvalign Technologies, Inc.KBH2023-06-23
G22313594910Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKBH2023-06-08
00887482192825Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBH2022-12-08
00887482192832Symmetry ASPEN SURGICAL PRODUCTS, INC.KBH2022-12-08
00842331170294Novo Surgical Inc. NOVO SURGICAL, INC.KBH2022-11-13
00190660000103Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04
00190660000110Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04
00190660000127Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04
00190660000134Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04
00190660000141Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04
00190660000158Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04
00190660000165Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04
00190660000172Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04