FDA.reportPublic FDA data

MENTIO disposable cerumen hook

Primary DI
04250676746627
Brand
MENTIO disposable cerumen hook
Company
Spiggle & Theis Medizintechnik GmbH
Model
5001009
Catalog number
5001009
Device description
black/PA6 100 pieces/box
Published
2025-10-07
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
04250676746627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250676746627042506767466274250676746627

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue surgical hook, single-useA hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. This is a single-use device.

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250676735614House hook10-643-3010-643-302022-09-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995271244V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
00724995271251V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
00724995271268V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
00724995271275V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
00724995271626V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
00724995271633V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
00724995271640V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
00724995271657V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
00724995271800V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
00724995273958V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
00724995273965V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
04054462901630evonosevonos GmbH & Co. KGJYG2026-08-21
04054462901647evonosevonos GmbH & Co. KGJYG2026-08-21
04054462901654evonosevonos GmbH & Co. KGJYG2026-08-21
04054462901661evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908134evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908141evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908158evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908165evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908172evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908189evonosevonos GmbH & Co. KGJYG2026-08-21
04054462901678evonosevonos GmbH & Co. KGJYG2026-08-18
04054462901685evonosevonos GmbH & Co. KGJYG2026-08-18
00190776422295MillenniumAvalign Technologies, Inc.JYG2026-07-31
00190776422356MillenniumAvalign Technologies, Inc.JYG2026-07-31
00190776422363MillenniumAvalign Technologies, Inc.JYG2026-07-31
00190776422370MillenniumAvalign Technologies, Inc.JYG2026-07-31
00190776422387MillenniumAvalign Technologies, Inc.JYG2026-07-31
00190776422394MillenniumAvalign Technologies, Inc.JYG2026-07-31
09348811100542INKAThe Trustee for KAISER FAMILY TRUSTJYG2026-07-31