FDA.reportPublic FDA data

Tontarra Medizintechnik GmbH

Primary DI
04050183356476
Brand
Tontarra Medizintechnik GmbH
Company
Tontarra Medizintechnik GmbH
Model
TONO/240-554-04KGCC
Device description
"PITUITARY Rongeur straight; 4mm width; coated 230mm (9.2"")"
Published
2019-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTXRongeur

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04050183356476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050183356476040501833564764050183356476

GMDN Terms#

Term, Definition table
TermDefinition
Bone punch, reusableA hand-held manual surgical instrument with a cutting/biting action used to cut small cross-sectional pieces of bone typically for biopsy or fixation procedures during a surgical intervention. It is typically designed with a long, thin, two-part sliding shaft (the upper part sliding along the lower part) which is joined to sprung (self-opening), pivoted, pistol grip handles. The working end terminates with a sharp, angled, cutting jaw that closes over an endpiece when the handles are squeezed together cutting through the bone. It is available in various sizes and designs (e.g., it can have upward or downward located jaws) and is 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
+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
04050183370182Tontarra Medizintechnik GmbHAR-2102022-08-23
04050183357336Tontarra Medizintechnik GmbH630-471-16 2020-03-18
04050183356469Tontarra Medizintechnik GmbHTONO/240-554-02KGCC2019-05-20
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
10840642182149Spine Wave InstrumentsSpine Wave, Inc.HTX2026-10-21
10840642182156Spine Wave InstrumentsSpine Wave, Inc.HTX2026-10-21
10840642182163Spine Wave InstrumentsSpine Wave, Inc.HTX2026-10-21
B382SD9228132200Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132300Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132310Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132340Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132350Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132360Surgical DirectSurgical Direct, Inc.HTX2026-10-20
00190776435394MillenniumAvalign Technologies, Inc.HTX2026-10-19
00190776434670MillenniumAvalign Technologies, Inc.HTX2026-10-12
00190776434687MillenniumAvalign Technologies, Inc.HTX2026-10-12
00190776434113MillenniumAvalign Technologies, Inc.HTX2026-10-09
B382SD922779120Surgical DirectSurgical Direct, Inc.HTX2026-10-09
B382SD9228051950Surgical DirectSurgical Direct, Inc.HTX2026-10-09
00190776436360MillenniumAvalign Technologies, Inc.HTX2026-10-08
B382SD914800210Surgical DirectSurgical Direct, Inc.HTX2026-09-30
B382SD30550860Surgical DirectSurgical Direct, Inc.HTX2026-09-29
B382SD546210000Surgical DirectSurgical Direct, Inc.HTX2026-09-29
B382SD9228131060Surgical DirectSurgical Direct, Inc.HTX2026-09-29
B382SD9228131070Surgical DirectSurgical Direct, Inc.HTX2026-09-29
00190776432546MillenniumAvalign Technologies, Inc.HTX2026-09-28
00724995267902Snowden-PencerSTERIS Deutschland GmbHHTX2026-09-25
00724995274597V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321390V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
B382SD482012L0Surgical DirectSurgical Direct, Inc.HTX2025-10-06
00840217909327Wiggins MedicalEBNER MEDICAL, LLCHTX2024-12-09
00840217908924Wiggins MedicalEBNER MEDICAL, LLCHTX2024-03-21
00840217908658Wiggins MedicalEBNER MEDICAL, LLCHTX2024-01-25
B382SD921226190Surgical DirectSurgical Direct, Inc.HTX2022-12-01