AccessGUDID - DEVICE: RZ Medizintechnik GmbH (04049197541985)

GUDID

Device Identifier (DI) Information

Brand Name: RZ Medizintechnik GmbH
Version or Model: 500-380-150
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 500-380-150
Company Name: RZ-Medizintechnik GmbH

Primary DI Number: 04049197541985
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312953227 *Terms of Use

Device Description: Ingrown Nail splitting Scissors one blade serrated 150mm (6")

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:	No
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?
38812	Nail scissors, reusable	A hand-held device designed specifically for cutting the nails of a patient. It is comprised of two pivoted blades with finger and thumb ring-handles, which cut the nails with a shearing action (i.e., the fine blades cut when the sharpened edges pass one another as they are closed); the blades may be curved to follow the natural curvature of human nails. It is not a pair of nail clippers. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRW	SCISSORS, GENERAL, SURGICAL

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 88e57c42-c6a7-4e43-a367-cd2f91fc42e5
Public Version Date: October 24, 2024
Public Version Number: 1
DI Record Publish Date: October 16, 2024