AccessGUDID - DEVICE: Humeca blade for Humby long knife (20cm/7.9 in) (08717903490242)

GUDID

Device Identifier (DI) Information

Brand Name: Humeca blade for Humby long knife (20cm/7.9 in)
Version or Model: 5.BLHUL/1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5.BLHUL/1
Company Name: Humeca B.V.

Primary DI Number: 08717903490242
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 489831498 *Terms of Use

Device Description: No description.

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):	No
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
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: 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: 49d49ae1-9a3d-4f2c-8532-890bd525b58c
Public Version Date: May 28, 2025
Public Version Number: 1
DI Record Publish Date: May 20, 2025