FDA.reportPublic FDA data

RZ Medizintechnik GmbH

Primary DI
04049197450379
Brand
RZ Medizintechnik GmbH
Company
RZ-Medizintechnik GmbH
Model
252-606-390
Catalog number
252-606-390
Device description
Sinuscopy Punch, double action Ø3mm, shaft 90° upwards curved, through cutting, horizontal opening, WL 130mm, 5
Published
2024-09-23
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
KAYPUNCH, NASAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAYPunch, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049197450379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049197450379040491974503794049197450379

GMDN Terms#

Term, Definition table
TermDefinition
ENT soft-tissue cutting forcepsA hand-held manual surgical instrument with a biting action intended to be used to punch/cut/excise soft-tissue during an ear/nose/throat (ENT) procedure [e.g., adenoidectomy, tonsillectomy, sinus surgery, septoplasty, and/or biopsy]. It is a metallic instrument with a distal mechanism designed to bite tissue when the handles are squeezed together; some types may be used endoscopically (e.g., through a laryngopharyngoscope), and may include an integrated fluid suction channel for improved surgical field viewing. It is not intended for cutting bone (i.e., not a rongeur). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49746294700info@rz-medizintechnik.com

Regulatory Flags#

DUNS number
312953227
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049197152594RZ Medizintechnik GmbH250-035-180250-035-1802024-10-16
04049197152624RZ Medizintechnik GmbH250-035-300250-035-3002024-10-16
04049197152648RZ Medizintechnik GmbH250-037-000250-037-0002024-10-16
04049197152662RZ Medizintechnik GmbH250-039-000250-039-0002024-10-16
04049197152679RZ Medizintechnik GmbH250-040-000250-040-0002024-10-16
04049197152686RZ Medizintechnik GmbH250-041-000250-041-0002024-10-16
04049197152693RZ Medizintechnik GmbH250-042-000250-042-0002024-10-16
04049197152723RZ Medizintechnik GmbH250-044-000250-044-0002024-10-16
04049197152747RZ Medizintechnik GmbH250-045-000250-045-0002024-10-16
04049197152754RZ Medizintechnik GmbH250-048-000250-048-0002024-10-16
04049197152761RZ Medizintechnik GmbH250-048-180250-048-1802024-10-16
04049197152778RZ Medizintechnik GmbH250-048-230250-048-2302024-10-16
04049197152785RZ Medizintechnik GmbH250-048-300250-048-3002024-10-16
04049197152860RZ Medizintechnik GmbH250-053-180250-053-1802024-10-16
04049197152877RZ Medizintechnik GmbH250-054-180250-054-1802024-10-16
04049197390668RZ Medizintechnik GmbH250-035-230250-035-2302024-10-16
04049197390675RZ Medizintechnik GmbH250-038-000250-038-0002024-10-16
04049197390729RZ Medizintechnik GmbH250-051-000250-051-0002024-10-16
04049197390743RZ Medizintechnik GmbH250-052-000250-052-0002024-10-16
04049197390750RZ Medizintechnik GmbH250-053-230250-053-2302024-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840183530693BR Surgical, LLCBR Surgical, LLCKAY2025-08-26
00840183530709BR Surgical, LLCBR Surgical, LLCKAY2025-08-26
00840183530716BR Surgical, LLCBR Surgical, LLCKAY2025-08-26
00840183530723BR Surgical, LLCBR Surgical, LLCKAY2025-08-26
00848657077194AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KAY2025-08-25
00194613081850MSI Precision Specialty InstrumentsMed Saver, Inc.KAY2025-08-01
00757770415847Bausch + LombBausch & Lomb IncorporatedKAY2025-07-31
00757770426256Bausch + LombBausch & Lomb IncorporatedKAY2025-07-31
00757770430840Bausch + LombBausch & Lomb IncorporatedKAY2025-07-31
00757770404667Bausch + LombBausch & Lomb IncorporatedKAY2024-11-20
00757770410842Bausch + LombBausch & Lomb IncorporatedKAY2024-11-20
00757770418541Bausch + LombBausch & Lomb IncorporatedKAY2024-11-20
00757770435531Bausch + LombBausch & Lomb IncorporatedKAY2024-11-20
00757770457748Bausch + LombBausch & Lomb IncorporatedKAY2024-11-19
04049197392938RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197392945RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197392952RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197449083RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197449090RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197449106RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197449113RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197450096RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197450102RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197450188RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197450195RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197450201RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197450232RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197450249RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197450256RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16
04049197524728RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAY2024-10-16