FDA.reportPublic FDA data

Caversaccio Tympano Sizer

Primary DI
04250676726889
Brand
Caversaccio Tympano Sizer
Company
Spiggle & Theis Medizintechnik GmbH
Model
10-609-02 TAN
Catalog number
10-609-02 TAN
Device description
shaft angled 2 mm, black coated
Published
2025-09-24
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
JYZROD, MEASURING EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYZRod, Measuring EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250676726889PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250676726889042506767268894250676726889

GMDN Terms#

Term, Definition table
TermDefinition
Dressing/utility forceps, scissors-like, reusableA hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

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
04250676726865Caversaccio Tympano SizerSpiggle & Theis Medizintechnik GmbHJYZ2024-11-11
00887482047644Symmetry HouseASPEN SURGICAL PRODUCTS, INC.JYZ2024-08-12
00887482113790Symmetry HouseASPEN SURGICAL PRODUCTS, INC.JYZ2024-08-12
00887482113806Symmetry HouseASPEN SURGICAL PRODUCTS, INC.JYZ2024-08-12
00887482113813Symmetry HouseASPEN SURGICAL PRODUCTS, INC.JYZ2024-08-12
00842331191091Novo SurgicalNOVO SURGICAL, INC.JYZ2023-12-18
G586E7214780Novo SurgicalNOVO SURGICAL, INC.JYZ2023-12-18
00190776044275AvalignAvalign Technologies, Inc.JYZ2023-11-13
00190776044299AvalignAvalign Technologies, Inc.JYZ2023-09-28
00190776319571MILLENNIUMAvalign Technologies, Inc.JYZ2023-09-28
00190776319588MILLENNIUMAvalign Technologies, Inc.JYZ2023-09-28
G043655090BEARBear-Ent, LLCJYZ2023-08-08
G043655100BEARBear-Ent, LLCJYZ2023-08-08
00190776369729MillenniumAvalign Technologies, Inc.JYZ2023-02-22
14026704805188PILLINGTELEFLEX INCORPORATEDJYZ2022-12-08
14026704805195PILLINGTELEFLEX INCORPORATEDJYZ2022-12-08
14026704805201PILLINGTELEFLEX INCORPORATEDJYZ2022-12-08
54026704805193PILLINGTELEFLEX INCORPORATEDJYZ2022-12-08
54026704805186PILLINGTELEFLEX INCORPORATEDJYZ2022-12-08
54026704805209PILLINGTELEFLEX INCORPORATEDJYZ2022-12-08
14026704805218PILLINGTELEFLEX INCORPORATEDJYZ2022-12-08
00842331174711Novo Surgical Inc. NOVO SURGICAL, INC.JYZ2022-11-14
00842331179525Novo Surgical Inc. NOVO SURGICAL, INC.JYZ2022-11-14
00840343700584Gen2SURGIX MEDICAL LLCJYZ2022-10-18
G277G2E9009610Gen2SURGIX MEDICAL LLCJYZ2022-09-23
04250676726872Caversaccio Tympano SizerSpiggle & Theis Medizintechnik GmbHJYZ2022-09-12
00190776044282AvalignAvalign Technologies, Inc.JYZ2021-11-03
00190776044305AvalignAvalign Technologies, Inc.JYZ2021-11-03
B351B655100BEARMytamed, Inc.JYZ2021-11-01
B351B655110BEARMytamed, Inc.JYZ2021-11-01