FDA.reportPublic FDA data

McKesson

Primary DI
20612479194995
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
16-157
Device description
Otoscope Tips GRAY DISPOSABLE 4.0mm
Published
2020-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
EPYSpeculum, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPYSpeculum, EntGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40612479195002PackageGS110In Commercial Distribution
20612479194995PrimaryGS10
10612479236162Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4061247919500240612479195002
2061247919499520612479194995
1061247923616210612479236162

GMDN Terms#

Term, Definition table
TermDefinition
Ear speculum, single-useA semi-rigid or rigid, plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may be referred to as an ear cannula. This is a single-use device.

Regulatory Flags#

DUNS number
023904428
Device count
1000
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20612479203710McKesson326302020-07-21
10612479169064McKesson101-87032016-12-09
10612479169125McKesson101-87102016-12-09
10612479284002McKesson16-6219-B2026-08-03
10612479284026McKesson16-6218-B2026-08-03
10612479284040McKesson16-6220-B2026-08-03
10612479284064McKesson16-6221-B2026-08-03
10612479284101McKesson16-6379-B2026-08-03
10612479284125McKesson16-6216-B2026-08-03
00612479151291McKesson16-DEN-12026-07-09
00612479274648McKesson48392025-01-17
20612479285723McKessonGCCOV-502a-MB2026-06-18
20612479285747McKessonCCOVAg-PNMB2026-06-18
00612479271050McKesson16-L2NWT6Y-XL2024-04-17
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054462156481evonosevonos GmbH & Co. KGEPY2026-08-26
04054462902286evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902293evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902309evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902316evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902330evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902385evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902408evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902415evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902422evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902439evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902446evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902453evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902460evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902477evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902484evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902491evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902507evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902514evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902521evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902538evonosevonos GmbH & Co. KGEPY2026-08-21
04054462904877evonosevonos GmbH & Co. KGEPY2026-08-21
04054462904884evonosevonos GmbH & Co. KGEPY2026-08-21
04054462904891evonosevonos GmbH & Co. KGEPY2026-08-21
04054462904907evonosevonos GmbH & Co. KGEPY2026-08-21
04054462904914evonosevonos GmbH & Co. KGEPY2026-08-21
04054462904938evonosevonos GmbH & Co. KGEPY2026-08-21
04054462904945evonosevonos GmbH & Co. KGEPY2026-08-21
04054462904952evonosevonos GmbH & Co. KGEPY2026-08-21
04054462904969evonosevonos GmbH & Co. KGEPY2026-08-21