AccessGUDID - DEVICE: RZ Medizintechnik GmbH (04049197518734)

GUDID

Device Identifier (DI) Information

Brand Name: RZ Medizintechnik GmbH
Version or Model: 225-820-219S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 225-820-219S
Company Name: RZ-Medizintechnik GmbH

Primary DI Number: 04049197518734
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312953227 *Terms of Use

Device Description: Needle with lateral opening 0,3x240mm f Suture Passer 225-820-217 sterile packed, package of 6pcs.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
17735	Arthroscopic suturing unit	A manually-operated, surgical device intended to be used in combination with a compatible arthroscope to mechanically approximate the edges of an internal wound or incision, including muscle tears, with sutures during arthroscopy. A suture punch mechanism places the number of sutures desired by the surgeon at the site of the lesion. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAB	NEEDLE, SUTURING, DISPOSABLE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7600fb24-8a7d-415f-a7ce-878f72fd976f
Public Version Date: June 27, 2024
Public Version Number: 1
DI Record Publish Date: June 19, 2024