FDA.reportPublic FDA data

RZ Medizintechnik GmbH

Primary DI
04049197508278
Brand
RZ Medizintechnik GmbH
Company
RZ-Medizintechnik GmbH
Model
295-000-110
Catalog number
295-000-110
Device description
Suture Catcher delicate, 2mm, 320mm
Published
2024-09-20
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
GDLNEEDLE, SUTURING, REUSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDLNeedle, Suturing, ReusableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049197508278PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049197508278040491975082784049197508278

GMDN Terms#

Term, Definition table
TermDefinition
Suturing unit, reusableA non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Sterilization required before use
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
00194613031718MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613040130MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613054878MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613084950MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613112493MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613112509MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613112622MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613112684MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613113308MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613119843MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613119850MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613119874MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613119881MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613119898MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613119911MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613121129MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613121136MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00190776401764MillenniumAvalign Technologies, Inc.GDL2025-06-13
00190776397715MillenniumAvalign Technologies, Inc.GDL2025-05-16
00194613106218MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-03-21
00194613114237MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-03-21
00194613119867MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-03-21
00194613119904MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-03-21
00194613119928MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-03-21
00190776390716MillenniumAvalign Technologies, Inc.GDL2024-11-19
G586OP7121290Novo SurgicalNOVO SURGICAL, INC.GDL2024-10-15
04049197022682RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDL2024-10-02
04049197022699RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDL2024-10-02
04049197455718RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDL2024-09-20
04049197455725RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDL2024-09-20