WiscMed

Primary DI
00850009819017
Brand
WiscMed
Company
WISC MED, LLC
Model
spec1-300
Device description
A single use, plastic, rigid, cone shaped, speculum designed specifically for use with the WiscMed Wispr digital otoscope. This item number consists of a quantity of 300 specula, packaged in plastic sleeves designed to fit traditional wall mounted specula holders found in most patient exam rooms.
Published
2020-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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
00850009819017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850009819017008500098190178500098190170850009819017

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6087297234wiscmedsupport@wiscmed.com

Regulatory Flags#

DUNS number
070666290
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850009819000WiscMedWispr247012020-03-27
00850009819024WiscMedspec1-962020-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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G141546073500Carnegie Surgical LLCCarnegie Surgical LLCEPY2026-09-30
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00810238290094PRINCETONPrinceton Medical Group, Inc.EPY2026-09-22
00810238290100PRINCETONPrinceton Medical Group, Inc.EPY2026-09-22
00810238290117PRINCETONPrinceton Medical Group, Inc.EPY2026-09-22
00810238290124PRINCETONPrinceton Medical Group, Inc.EPY2026-09-22
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