AccessGUDID - DEVICE: RZ Medizintechnik GmbH (04049197420907)

GUDID

Device Identifier (DI) Information

Brand Name: RZ Medizintechnik GmbH
Version or Model: 190-209-183
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 190-209-183
Company Name: RZ-Medizintechnik GmbH

Primary DI Number: 04049197420907
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312953227 *Terms of Use

Device Description: Universal clothing plaster shear YELLOW 180mm, 7", blunt, with pastic rings with plastic protection cap,autoclavable

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?
46314	Cast cutting scissors	A hand-held surgical instrument with specially strong, curved blades that is used to cut small plaster cast dressings and layers of thick material, e.g., bandages. It is designed like a strong pair of scissors with two pivoted blades usually provided with finger and thumb holes in the handles. The distal end of the blades may be different shapes and are usually rounded or have a pod at the tip for safety. The longest blade is inserted between the body surface and the plaster cast and pressure is exerted upon the handles by squeezing them together to create the cutting effect. It is typically made of high-grade stainless steel. 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: c37fc086-6796-4ca1-9ab6-d4538ad15fb1
Public Version Date: July 03, 2024
Public Version Number: 1
DI Record Publish Date: June 25, 2024