AccessGUDID - DEVICE: 2-inch ASD Excision ring blade (00810006780086)

GUDID

Device Identifier (DI) Information

Brand Name: 2-inch ASD Excision ring blade
Version or Model: X101789
Commercial Distribution Status: In Commercial Distribution
Catalog Number: X101789
Company Name: EXSURCO MEDICAL, INC.

Primary DI Number: 00810006780086
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 079319210 *Terms of Use

Device Description: Amalgatome SD Surgical Skin Grafting and Debridement Blade

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:	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
Storage Environment Humidity: between 30 and 70 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 2 Inch

Device Record Status

Public Device Record Key: 2928065c-0af1-49d2-a9b6-6a1c47e94de0
Public Version Date: June 22, 2021
Public Version Number: 2
DI Record Publish Date: February 18, 2021