AccessGUDID - DEVICE: Swann Morton Ltd. (05033955120504)

GUDID

Device Identifier (DI) Information

Brand Name: Swann Morton Ltd.
Version or Model: PARAGON STERILE SKIN GRAFT BLADES
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PS50
Company Name: SWANN-MORTON LIMITED

Primary DI Number: 05033955120504
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 212397483 *Terms of Use

Device Description: Dermatome -A surgical instrument used for harvesting skin for grafting purposes.

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
FZW	Expander, Surgical, Skin Graft

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: 7fd47b28-a33b-4a5e-93d2-3d4e9f070ddf
Public Version Date: June 07, 2022
Public Version Number: 1
DI Record Publish Date: May 30, 2022