AccessGUDID - DEVICE: Blade for Dermatome 100mm (ENOU19199)

GUDID

Device Identifier (DI) Information

Brand Name: Blade for Dermatome 100mm
Version or Model: 1919
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Nouvag AG

Primary DI Number: ENOU19199
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 480610476 *Terms of Use

Device Description: Blade for Dermatome 100mm

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":	No
For Single-Use:	Yes
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?
35134	Dermatome blade, single-use	A surgical cutting device that is designed to be mounted onto a dermatome handle/handpiece (not included) and used to provide the cutting edge for the harvesting of skin grafts or excision of small skin lesions. It is available in various sizes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GFD	Dermatome

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: bb0c0c67-8f8a-49e6-a815-2e2bcc55f9ae
Public Version Date: June 22, 2021
Public Version Number: 2
DI Record Publish Date: August 21, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: ENOU19190 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +41718466600
Email: info@nouvag.com

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