FDA.reportPublic FDA data

Politzer ear speculum for children

Primary DI
04250676730497
Brand
Politzer ear speculum for children
Company
Spiggle & Theis Medizintechnik GmbH
Model
10-202-03
Catalog number
10-202-03
Device description
size 3 OD 5.5 mm, ID 4.0 mm
Published
2022-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
04250676730497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250676730497042506767304974250676730497

GMDN Terms#

Term, Definition table
TermDefinition
Ear speculum, reusableA 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 in addition be intended for use with an audiometer and might also be referred to as an ear cannula or probe. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+492206908165c.winterschladen@spiggle-theis.com

Regulatory Flags#

DUNS number
332893028
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

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G04371403G0GEIZBear-Ent, LLCEPY2026-05-07
09348811116673INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-04-24
09348811116925INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-03-18
09348811116345INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116369INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116383INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116406INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116413INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811148995INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
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08906039319521OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
08906039319538OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
08906039319545OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
G043608500BEARBear-Ent, LLCEPY2022-05-23
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