FDA.reportPublic FDA data

Antrum curette

Primary DI
04250381813201
Brand
Antrum curette
Company
Spiggle & Theis Medizintechnik GmbH
Model
30-205-03
Catalog number
30-205-03
Device description
oval, large, 45° angled 4.0x9.0 mm
Published
2022-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
04250381813201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250381813201042503818132014250381813201

GMDN Terms#

Term, Definition table
TermDefinition
Paranasal sinus curetteA slender, hand-held, manual surgical instrument designed for scraping and/or excising tissue from one of the paranasal sinuses (i.e., frontal, sphenoidal, ethmoidal, maxillary). The distal end of the instrument is finished in an appropriate shape (e.g., cup-, ring-, spoon-like) according to the procedure to be performed; the device is typically made of high-grade stainless steel and is available in a variety of shapes and sizes. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04251993601927Tray set with flex band and pier pin1000616-12-011000616-12-012025-12-03
04251993601934Tray set with flex band1000617-31000617-32025-12-03
04250381821503Gillies skin hook6-1240/186-1240/182025-09-29
04250676710017Hook85-900-0185-900-012025-09-29
04250676711625ForkAHA-0147AHA-01472025-09-29
04250676716880ENT-single-use suction tubes, angled301302030130202025-09-29
04250676716897ENT-single-use suction tubes, angled301303030130302025-09-29
04250676731982Salivary duct probe40-611-0040-611-002025-09-29
04250676731999Salivary duct probe40-611-0140-611-012025-09-29
04250676732002Salivary duct probe40-611-0240-611-022025-09-29
04250676732026Salivary duct probe40-611-0440-611-042025-09-29
04250676732033Salivary duct probe40-611-0540-611-052025-09-29
04250676740625Bowman salivary duct probe40-609-4040-609-402025-09-29
04250676740632Bowman salivary duct probe40-609-0040-609-002025-09-29

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