FDA.reportPublic FDA data

Metal bowl

Primary DI
04250381891964
Brand
Metal bowl
Company
Spiggle & Theis Medizintechnik GmbH
Model
80-501-03
Catalog number
80-501-03
Device description
B4 Ø 85 mm, height 40 mm, 160 ml
Published
2025-10-16
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
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
04250381891964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250381891964042503818919644250381891964

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose bowl, reusableA portable bowl or basin designed to be used for a variety of medical purposes such as containing fluids, carrying or holding instruments prior to or during a procedure, and collecting body waste or other matter. The design and shape can vary including round, oblong, deep or quite shallow. 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

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
04250676750891Billeau ear loopSpiggle & 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