AccessGUDID - DEVICE: RZ Medizintechnik GmbH (04049197316019)

GUDID

Device Identifier (DI) Information

Brand Name: RZ Medizintechnik GmbH
Version or Model: 420-553-170
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 420-553-170
Company Name: RZ-Medizintechnik GmbH

Primary DI Number: 04049197316019
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312953227 *Terms of Use

Device Description: Ward Periosteal Elevator, fan shape 170mm, 5.5mm fan shape

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?
35048	Bone lever/elevator, reusable	A manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KAD	ELEVATOR, ENT

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: 826b8f26-8409-4e10-9eb7-51c6885fa7de
Public Version Date: July 08, 2024
Public Version Number: 1
DI Record Publish Date: June 28, 2024