FDA.reportPublic FDA data

Billeau ear loop

Primary DI
04250676750891
Brand
Billeau ear loop
Company
Spiggle & Theis Medizintechnik GmbH
Model
M1026301
Catalog number
M1026301
Device description
size 1, straight 3x5 mm, 16.5 cm
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
LRCINSTRUMENT, ENT MANUAL SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250676750891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250676750891042506767508914250676750891

GMDN Terms#

Term, Definition table
TermDefinition
Ear snareA hand-held manual surgical instrument intended to be inserted through the outer ear canal or through a surgical incision in the ear to remove tissue, typically tumorous or damaged tissue, from the ear during ear/nose/throat (ENT) surgery. It typically consists of a cannula-like tube with two stationary and one sliding finger rings designed to position and tighten a loop of thin, flexible wire (the snare) around the tissue to be removed. It is intended for mechanical cutting only (i.e., not through electrical ablation). 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
04250676750785Hartmann ear speculumM1020002M10200022026-10-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250676750815Lucae cerumen hookSpiggle & Theis Medizintechnik GmbHLRC2026-10-28
04250676750822Lucae cerumen hookSpiggle & Theis Medizintechnik GmbHLRC2026-10-28
04250676750839Lucae cerumen hookSpiggle & Theis Medizintechnik GmbHLRC2026-10-28
04250676750907Billeau ear loopSpiggle & Theis Medizintechnik GmbHLRC2026-10-28
04250676750914Billeau ear loopSpiggle & Theis Medizintechnik GmbHLRC2026-10-28
04250676750921Snellen ear loopSpiggle & Theis Medizintechnik GmbHLRC2026-10-28
04250676750938Snellen ear loopSpiggle & Theis Medizintechnik GmbHLRC2026-10-28
B382SD67371410Surgical DirectSurgical Direct, Inc.LRC2026-10-28
B382SD9114681000Surgical DirectSurgical Direct, Inc.LRC2026-10-28
00190776423070MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435813MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435820MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435837MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435844MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435851MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435868MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776436735MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776436742MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776436759MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435417MillenniumAvalign Technologies, Inc.LRC2026-10-19
00190776434946MillenniumAvalign Technologies, Inc.LRC2026-10-14
00190776434977MillenniumAvalign Technologies, Inc.LRC2026-10-14
00190776434618MillenniumAvalign Technologies, Inc.LRC2026-10-09
00198506095795ELMED INCORPORATEDELMED INCORPORATEDLRC2026-10-09
00190776433529MillenniumAvalign Technologies, Inc.LRC2026-10-06
00192896123854Gum ScissorsSONTEC INSTRUMENTS, INC.LRC2026-10-06
00190776433093MillenniumAvalign Technologies, Inc.LRC2026-10-01
00190776432539MillenniumAvalign Technologies, Inc.LRC2026-09-28
00190776432263MillenniumAvalign Technologies, Inc.LRC2026-09-24
00190776432270MillenniumAvalign Technologies, Inc.LRC2026-09-24