AccessGUDID - DEVICE: RZ Medizintechnik GmbH (04049197499262)

GUDID

Device Identifier (DI) Information

Brand Name: RZ Medizintechnik GmbH
Version or Model: 290-101-600
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 290-101-600
Company Name: RZ-Medizintechnik GmbH

Primary DI Number: 04049197499262
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312953227 *Terms of Use

Device Description: Gigli Wire Saw Ø1,4mm, 600mm, 24"

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?
44982	Manual surgical saw blade, flexible, reusable	A flexible, wire-like, metal surgical instrument, usually of a high-grade stainless steel, typically intended to be used in orthopaedic or neurological surgery to cut bone. It has a serrated surface, or a surface coated with an abrasive material, and functions as the cutting blade of a flexible manual hand saw commonly known as a Gigli saw. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDR	SAW, MANUAL AND ACCESSORIES

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: 7dd37b1f-9b5d-4eb5-82df-7f6225eaad3e
Public Version Date: September 30, 2024
Public Version Number: 1
DI Record Publish Date: September 20, 2024