FDA.reportPublic FDA data

Caversaccio Tympano Sizer

Primary DI
04250676726872
Brand
Caversaccio Tympano Sizer
Company
Spiggle & Theis Medizintechnik GmbH
Model
10-609-04 TAN
Catalog number
10-609-04 TAN
Device description
shaft angled 4 mm, black coated
Published
2022-09-12
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
04250676726872PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250676726872042506767268724250676726872

GMDN Terms#

Term, Definition table
TermDefinition
Surgical depth gauge, reusableA surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. 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
04250676726889Caversaccio Tympano SizerSpiggle & Theis Medizintechnik GmbHJYZ2025-09-24
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
00190776044282AvalignAvalign Technologies, Inc.JYZ2021-11-03
00190776044305AvalignAvalign Technologies, Inc.JYZ2021-11-03
B351B655100BEARMytamed, Inc.JYZ2021-11-01
B351B655110BEARMytamed, Inc.JYZ2021-11-01