AccessGUDID - DEVICE: RZ Medizintechnik GmbH (04049197410922)

GUDID

Device Identifier (DI) Information

Brand Name: RZ Medizintechnik GmbH
Version or Model: 110-096-180
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 110-096-180
Company Name: RZ-Medizintechnik GmbH

Primary DI Number: 04049197410922
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312953227 *Terms of Use

Device Description: GOULIAN dermatome, complete 180mm, 7", with 3 grafting templates complete with 5ea spare blades

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?
65578	Dermatome set, manual	A collection of non-powered devices which includes a durable dermatome handle and disposable or reusable blades designed to cut from the body (harvest) thin donor slices of skin for skin grafting or to excise small skin lesions. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GES	BLADE, SCALPEL

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: b0dfe73f-8cc0-4aa8-bc0f-89dab245a0c0
Public Version Date: October 10, 2024
Public Version Number: 1
DI Record Publish Date: October 02, 2024