FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780418832
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
19-172
Catalog number
19-172
Device description
Integra® Miltex® Uebe Cotton Applicator, 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
10381780418832PrimaryGS10
H834191720SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178041883210381780418832

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7Inch

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
10381780518525CODMAN® HAKIM®82300782-30072020-06-02
10381780518532CODMAN® HAKIM®82300882-30082020-06-02
10381780518600CODMAN® HAKIM®82301582-30152020-06-02
10381780518716CODMAN® HAKIM®82302682-30262020-06-02
10381780518761CODMAN® HAKIM®82303582-30352020-06-02
10381780518808CODMAN® HAKIM®82303982-30392020-06-02
10381780518976CODMAN® HAKIM®82308282-30822020-06-02
10381780519010CODMAN® HAKIM®82308682-30862020-06-02
10381780519089CODMAN® HAKIM®82309782-30972020-06-02
10381780519195CODMAN® HAKIM®82311682-31162020-06-02
10381780519249CODMAN® HAKIM®82316482-31642020-06-02
10381780519256CODMAN® HAKIM®82318282-31822020-06-02
10381780519263CODMAN® HAKIM®82318482-31842020-06-02
10381780519447CODMAN® HAKIM®82328182-32812020-06-02
10381780519478CODMAN® HAKIM®82328482-32842020-06-02
10381780519485CODMAN® HAKIM®82328582-32852020-06-02
10381780519751CODMAN® HAKIM®82382182-38212020-06-02
10381780519768CODMAN® HAKIM®82382282-38222020-06-02
10381780519799CODMAN® HAKIM®82382582-38252020-06-02
10381780519805CODMAN® HAKIM®82383282-38322020-06-02

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