FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780418894
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
19-192
Catalog number
19-192
Device description
"Integra® Miltex® Lathbury Cotton Applicator 5-1/2"", Cross-Serrated Tip"
Published
2017-12-21
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
KCJAPPLICATOR, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCJApplicator, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780418894PrimaryGS10
H834191920SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178041889410381780418894

GMDN Terms#

Term, Definition table
TermDefinition
ENT powder applicatorAn applicator designed to utilize blowing air, typically through the use of a hand-operated bulb, to administer powdered medication to the ear, nose, or oral cavity/throat during an ear/nose/throat (ENT) procedure or treatment. 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
04054462901265evonosevonos GmbH & Co. KGKCJ2026-08-18
04054462901289evonosevonos GmbH & Co. KGKCJ2026-08-18
04054462901296evonosevonos GmbH & Co. KGKCJ2026-08-18
04054462901302evonosevonos GmbH & Co. KGKCJ2026-08-18
04054462901326evonosevonos GmbH & Co. KGKCJ2026-08-18
04054462901333evonosevonos GmbH & Co. KGKCJ2026-08-18
04054462901340evonosevonos GmbH & Co. KGKCJ2026-08-18
04054462903146evonosevonos GmbH & Co. KGKCJ2026-08-18
04054462918133evonosevonos GmbH & Co. KGKCJ2026-08-18
04054462915132evonosevonos GmbH & Co. KGKCJ2026-08-17
04054462916801evonosevonos GmbH & Co. KGKCJ2026-08-14
04054462916825evonosevonos GmbH & Co. KGKCJ2026-08-14
00757770410972Bausch + LombBausch & Lomb IncorporatedKCJ2025-07-29
00757770420179Bausch + LombBausch & Lomb IncorporatedKCJ2025-07-29
00757770420766Bausch + LombBausch & Lomb IncorporatedKCJ2025-07-29
00757770427383Bausch + LombBausch & Lomb IncorporatedKCJ2025-07-29
00850027492698NavägeRhinosystems, Inc.KCJ2024-11-15
00887482037898Symmetry FarrellASPEN SURGICAL PRODUCTS, INC.KCJ2024-08-15
00840183517489BR Surgical, LLCBR Surgical, LLCKCJ2024-05-29
04055207009734NARichard Wolf GmbHKCJ2024-05-21
00850022483073Saline Noze MistDr. Noze Best, LLCKCJ2024-02-05
G586E1032750Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E1035960Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032250Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032270Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032290Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032750Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032770Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032790Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91035460Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18