FDA.reportPublic FDA data

Tontarra Medizintechnik GmbH

Primary DI
04050183370182
Brand
Tontarra Medizintechnik GmbH
Company
Tontarra Medizintechnik GmbH
Model
AR-210
Device description
Alar Retraktor
Published
2022-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KALRetractor, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KALRetractor, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04050183370182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050183370182040501833701824050183370182

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue surgical hook, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+497461965760info@tontarra.de

Regulatory Flags#

DUNS number
328192679
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04050183370533Tontarra Medizintechnik GmbHST-02022-09-20
04050183370540Tontarra Medizintechnik GmbHST-702022-09-20
04050183370557Tontarra Medizintechnik GmbHST-902022-09-20
04050183357336Tontarra Medizintechnik GmbH630-471-16 2020-03-18
04050183356469Tontarra Medizintechnik GmbHTONO/240-554-02KGCC2019-05-20
04050183356476Tontarra Medizintechnik GmbHTONO/240-554-04KGCC2019-05-20
04050183356483Tontarra Medizintechnik GmbHTONO/240-554-06KGCC2019-05-20
04050183353536Tontarra Medizintechnik GmbH240-604-06KGCC2018-09-26
04050183353529Tontarra Medizintechnik GmbH240-604-04KGCC 2018-09-25
04050183353512Tontarra Medizintechnik GmbH240-604-02KGCC2018-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995275235V. MuellerSTERIS Deutschland GmbHKAL2026-10-21
00724995328788V. MuellerSTERIS Deutschland GmbHKAL2026-10-21
00190776432607MillenniumAvalign Technologies, Inc.KAL2026-09-28
00724995327408V. MuellerSTERIS Deutschland GmbHKAL2026-09-25
00724995327422V. MuellerSTERIS Deutschland GmbHKAL2026-09-25
00841536148602ThompsonThompson Surgical Instruments, Inc.KAL2026-09-20
00841536148619ThompsonThompson Surgical Instruments, Inc.KAL2026-09-20
00841536148626ThompsonThompson Surgical Instruments, Inc.KAL2026-09-20
00841536148633ThompsonThompson Surgical Instruments, Inc.KAL2026-09-20
00190776429065MillenniumAvalign Technologies, Inc.KAL2026-09-04
04054462156498evonosevonos GmbH & Co. KGKAL2026-08-26
04054462156504evonosevonos GmbH & Co. KGKAL2026-08-26
04054462913039evonosevonos GmbH & Co. KGKAL2026-08-26
00190776417253MillenniumAvalign Technologies, Inc.KAL2026-08-19
00190776417710MillenniumAvalign Technologies, Inc.KAL2026-08-19
04054462913060evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913077evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913091evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913107evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913114evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913121evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913138evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913145evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913169evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913213evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913237evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913251evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913275evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913152evonosevonos GmbH & Co. KGKAL2026-08-18
04054462915828evonosevonos GmbH & Co. KGKAL2026-08-17