FDA.reportPublic FDA data

Hartmann ear speculum

Primary DI
04250676750785
Brand
Hartmann ear speculum
Company
Spiggle & Theis Medizintechnik GmbH
Model
M1020002
Catalog number
M1020002
Device description
size 2 OD 5.0 mm, ID 4.0 mm
Published
2026-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
04250676750785PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250676750785042506767507854250676750785

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250676750662Farrior ear speculumM1018601M10186012026-10-28
04250676750679Farrior ear speculumM1018602M10186022026-10-28
04250676750686Farrior ear speculumM1018604M10186042026-10-28
04250676750693Farrior ear speculumM1018603M10186032026-10-28
04250676750709Farrior ear speculumM1018605M10186052026-10-28
04250676750716Farrior ear speculumM1018606M10186062026-10-28
04250676750723Farrior ear speculumM1018607M10186072026-10-28
04250676750730Farrior ear speculumM1018608M10186082026-10-28
04250676750761Hartmann ear speculumM1020000M10200002026-10-28
04250676750778Hartmann ear speculumM1020001M10200012026-10-28
04250676750792Hartmann ear speculumM1020003M10200032026-10-28
04250676750808Hartmann ear speculumM1020004M10200042026-10-28
04250676750815Lucae cerumen hookM1025001M10250012026-10-28
04250676750822Lucae cerumen hookM1025002M10250022026-10-28
04250676750839Lucae cerumen hookM1025003M10250032026-10-28
04250676750846Buck ear curetteM1026001M10260012026-10-28
04250676750853Buck ear curetteM1026002M10260022026-10-28
04250676750860Buck ear curetteM1026003M10260032026-10-28
04250676750877Buck ear curetteM1026010M10260102026-10-28
04250676750884Buck ear curetteM1026020M10260202026-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250676750662Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750679Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750686Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750693Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750709Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750716Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750723Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750730Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750761Hartmann ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750778Hartmann ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750792Hartmann ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750808Hartmann ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750945Tieck-Halle nasal speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750952Tieck-Halle nasal speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750969Vienna model nasal speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750976Hartmann-Halle nasal speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750983Hartmann-Halle nasal speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750990Hartmann-Halle nasal speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751003Killian septum speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751010Killian septum speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751027Killian septum speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751041Le Mee ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751058Le Mee ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751065Le Mee ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751072Le Mee ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751089Le Mee ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751096Le Mee ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751102Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751119Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751126Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28