FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
10381780199946
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
430126
Catalog number
430-126
Device description
Integra® Jarit® Shambaugh Adenotome Blade for REF# 430-120, 12mm Wide, Size 1, Small
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
10381780199946PrimaryGS10
M2744301261SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178019994610381780199946

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
10381780191070Integra® Jarit®400293400-2932018-04-02
10381780193180Integra® Jarit®P408P4082018-04-02
10381780197997Integra® Jarit®380232380-2322017-09-29
10381780198000Integra® Jarit®380233380-2332018-03-22
10381780198543Integra® Jarit®385295385-2952018-03-22
10381780220121Integra® Jarit®P666P6662018-01-31
10381780390381Integra® Jarit®380230380-2302018-02-16
10381780390398Integra® Jarit®380231380-2312018-02-16
10381780456469Integra® Jarit®405225405-2252018-01-31
10381780457190Integra® Jarit®P667P6672018-01-31
10381780458159Integra® Jarit®385315385-3152018-03-01
10381780458166Integra® Jarit®385316385-3162018-03-01
10381780487708Integra® Miltex®MH21-300MH21-3002018-08-22
10381780503910Integra® Miltex®PM-666PM-6662020-10-01
10381780520665CereLink™82684582-68452020-04-01
10381780087984Integra®375001237500122018-10-26
10381780081371Integra®372201137220112018-10-24
10381780081388Integra®372201237220122018-10-24
10381780081906Integra®372206937220692018-10-24
10381780081913Integra®372207037220702018-10-24

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