FDA.reportPublic FDA data

Solution bowl

Primary DI
04250676740014
Brand
Solution bowl
Company
Spiggle & Theis Medizintechnik GmbH
Model
80-505-10
Catalog number
80-505-10
Device description
stainless steel Ø 72 mm, height 33 mm, 100 ml
Published
2025-09-19
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
EPWSupport, head, surgical, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPWSupport, Head, Surgical, EntGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250676740014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250676740014042506767400144250676740014

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
04250676736000Fiberglass light carrier50-231-0150-231-012025-09-15
04250676736024Fiberglass light carrier50-231-0350-231-032025-09-15
04250676736031Fiberglass light carrier50-234-0150-234-012025-09-15
04250676736055Fiberglass light carrier50-234-0350-234-032025-09-15
04250381858387Fiberglass light carrier for rigid and50-205-1250-205-122022-09-27
04250381858394Fiberglass lightcarrier for rigid and50-205-3650-205-362022-09-27
04250381858400Fiberglass lightcarrier for rigid and50-205-7050-205-702022-09-27
04250381858509Fiberglass lightcarrier for laser50-217-1250-217-122022-09-27
04250381858516Fibreglass light carrier for laser50-217-3650-217-362022-09-27
04250381858523Fiberglass lightcarrier for laser50-217-7050-217-702022-09-27
04250676736048Fiberglass light carrier50-234-0250-234-022022-09-27
04250676701800Fibre light carrier20-155-0020-155-002022-09-14
04250676748188Endoragard teeth protector50-240-0050-240-002026-04-27
04250676748195Medasil teeth protector50-250-0050-250-002022-09-27
04050659354647Brünings anastignatic aural magnifier10-180-0010-180-002026-01-21
04250676747204Tray set with flex band and pier pin1000616-12-011000616-12-012025-12-03
04250676747211Tray set with flex band1000617-31000617-32025-12-03
04250676747235Filter modul with 8 x LM10-845-0110-845-012025-12-03
04250676747228Tray set1000617-3-01000617-3-02025-12-03
04251993600128Filter modul with 8 x LM10-845-0110-845-012025-12-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250381851463Forceps holderSpiggle & Theis Medizintechnik GmbHEPW2025-09-25
04250381862520Solution bowlSpiggle & Theis Medizintechnik GmbHEPW2025-09-19
04250676740007Solution bowlSpiggle & Theis Medizintechnik GmbHEPW2025-09-19
04250676740021Metal cupSpiggle & Theis Medizintechnik GmbHEPW2025-09-19
00810075280999Bone FoamBONE FOAM, INC.EPW2022-05-22
00810075281002Bone FoamBONE FOAM, INC.EPW2022-05-22
00810075280104BoneFoamBONE FOAM, INC.EPW2022-05-22
20681490013240N/AMEDTRONIC XOMED, INC.EPW2021-07-04
00681490039017Bio-FlekMEDTRONIC XOMED, INC.EPW2021-07-04
00681490039024Bio-FlekMEDTRONIC XOMED, INC.EPW2021-07-04
00681490013246N/AMEDTRONIC XOMED, INC.EPW2021-07-04
00763000299101Bio-FlekMEDTRONIC XOMED, INC.EPW2021-04-25
00763000299118Bio-FlekMEDTRONIC XOMED, INC.EPW2021-04-25
00811304020539"Voss 9"" Round Support"VM/POSITIONING, INC.EPW2018-06-11
00821925037731GYRUS ACMI Gyrus ACMI, LLCEPW2015-10-24