AccessGUDID - DEVICE: Amalgatome SD 2-inch Lock Ring (00810006780055)

GUDID

Device Identifier (DI) Information

Brand Name: Amalgatome SD 2-inch Lock Ring
Version or Model: X100768
Commercial Distribution Status: In Commercial Distribution
Catalog Number: X100768
Company Name: EXSURCO MEDICAL, INC.

Primary DI Number: 00810006780055
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079319210 *Terms of Use

Device Description: Lock Ring 2" ASD

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:	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?
37473	Dermatome handpiece, pneumatic	A pneumatically-powered, hand-held surgical instrument designed to cut from the body (harvest) thin donor slices of skin for skin grafting, or to excise small skin lesions, using a dedicated insertable blade (not included). This instrument will typically be driven by compressed gas [e.g., surgical-grade air, nitrogen (N2)] from a medical gas supply system. This is a reusable 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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 2 Inch

Device Record Status

Public Device Record Key: 3682a8a2-9586-4d76-ae55-e3d1c4decb99
Public Version Date: June 22, 2021
Public Version Number: 2
DI Record Publish Date: January 12, 2021