FDA.reportPublic FDA data

Ear curette

Primary DI
04250676704740
Brand
Ear curette
Company
Spiggle & Theis Medizintechnik GmbH
Model
10-259-01
Catalog number
10-259-01
Device description
size 1, ring straight, blunt shaft angled, 14 cm
Published
2022-09-09
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
JYGCURETTE, EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYGCurette, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250676704740PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250676704740042506767047404250676704740

GMDN Terms#

Term, Definition table
TermDefinition
Endaural surgical curette, reusableA slender, hand-held, manual surgical instrument designed for procedures during middle ear surgery (e.g., removal of the superior bony rim), and may in addition be used for scraping within the ear canal (e.g., removing wax). The instrument has a serrated or blunt loop, or hook, at its distal end that may be straight, slightly curved, or angled; it is typically made of high-grade stainless steel. 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
00190776418069MillenniumAvalign Technologies, Inc.JYG2026-03-23
00192896111783Buck Ear CuretteSONTEC INSTRUMENTS, INC.JYG2026-02-26
00192896111790Buck Ear CuretteSONTEC INSTRUMENTS, INC.JYG2026-02-26
00192896111806Buck Ear CuretteSONTEC INSTRUMENTS, INC.JYG2026-02-26
00192896111813Buck Ear CuretteSONTEC INSTRUMENTS, INC.JYG2026-02-26
00192896111820Buck Ear CuretteSONTEC INSTRUMENTS, INC.JYG2026-02-26
00192896111837Buck Ear CuretteSONTEC INSTRUMENTS, INC.JYG2026-02-26
00190776416478MillenniumAvalign Technologies, Inc.JYG2026-02-16
00190776416485MillenniumAvalign Technologies, Inc.JYG2026-02-16
00757770672080Bausch + LombBausch & Lomb IncorporatedJYG2025-12-12
04250676716422Buck ear curetteSpiggle & Theis Medizintechnik GmbHJYG2025-09-25
04250381855461Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381855478Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381855973Spoon curetteSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381855980Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381855997Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856000Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856017Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856024Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856031Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856086Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856093Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856109Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856116Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381863329Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381863336Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381863343Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381863350Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381862490Tisch micro curetteSpiggle & Theis Medizintechnik GmbHJYG2025-09-11
00190776409357MillenniumAvalign Technologies, Inc.JYG2025-08-25