FDA.reportPublic FDA data

Tontarra Medizintechnik GmbH

Primary DI
04050183370540
Brand
Tontarra Medizintechnik GmbH
Company
Tontarra Medizintechnik GmbH
Model
ST-70
Device description
MiniFESS Curved Suction 70° Stryker Ref. ST-70
Published
2022-09-20
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
KCBTube, Tonsil Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCBTube, Tonsil SuctionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04050183370540PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050183370540040501833705404050183370540

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated tube designed as a conduit for irrigation and aspiration (i.e., capable of both functions) of body cavities/wounds during a surgical procedure (e.g., neurosurgery, laparoscopy), typically to facilitate observation. It is not dedicated to dental or intrauterine procedures, not an ophthalmic device, and is not designed to administer parenteral fluids or drugs. It might incorporate a handle with a valve(s) and hole(s) on its side for the control of irrigation/aspiration, and may be provided with a stylet, a sheath, and/or connection tubing; it is typically made of metal. 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
04050183370557Tontarra Medizintechnik GmbHST-902022-09-20
04050183370182Tontarra Medizintechnik GmbHAR-2102022-08-23
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
00190776423919MillenniumAvalign Technologies, Inc.KCB2026-08-26
00190776426460MillenniumAvalign Technologies, Inc.KCB2026-08-18
00190776426477MillenniumAvalign Technologies, Inc.KCB2026-08-18
00190776408831MillenniumAvalign Technologies, Inc.KCB2026-08-03
B382SD9114061030Surgical DirectSurgical Direct, Inc.KCB2026-07-23
00840183531690BR Surgical, LLCBR Surgical, LLCKCB2026-07-16
00840183532635BR Surgical, LLCBR Surgical, LLCKCB2026-07-16
B382SD48301400Surgical DirectSurgical Direct, Inc.KCB2026-03-09
B382SD911451080Surgical DirectSurgical Direct, Inc.KCB2026-03-02
B382SD6770650Surgical DirectSurgical Direct, Inc.KCB2026-02-06
B382SD9194441080Surgical DirectSurgical Direct, Inc.KCB2026-02-06
B382SD920223100Surgical DirectSurgical Direct, Inc.KCB2026-02-06
B382SD9204111140Surgical DirectSurgical Direct, Inc.KCB2026-02-06
B382SD9227771100Surgical DirectSurgical Direct, Inc.KCB2026-02-06
B382SD49301300Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD4930130450Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD61042070Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD6786020Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD911430081A0Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD91143014A0Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD911431107A0Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD9114511180Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD9114511490Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD9114511500Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD9114511680Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD911454070Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD920860310Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD920860320Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD920860330Surgical DirectSurgical Direct, Inc.KCB2026-02-05
B382SD920860340Surgical DirectSurgical Direct, Inc.KCB2026-02-05