AccessGUDID - DEVICE: Anmuth Medical International (08403207009340)

GUDID

Device Identifier (DI) Information

Brand Name: Anmuth Medical International
Version or Model: 72-181-16
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 72-181-16
Company Name: Anmuth Medical International, LLC

Primary DI Number: 08403207009340
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 786500830 *Terms of Use

Device Description: Pitanguy Flap Demarcator small, 5.0 mm wide, 6-1/4" (15.9 cm)

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):	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?
12442	Corneal marker, single-use	A manual instrument intended to be used to ink mark corneal tissue prior to an ophthalmic surgical procedure. It is a pen-like device typically with a weighted self-levelling mechanism. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZZ	MARKER, SKIN

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 6.25 Inch

Device Record Status

Public Device Record Key: fda97b00-9782-4391-83d8-df83a837fe47
Public Version Date: February 20, 2025
Public Version Number: 1
DI Record Publish Date: February 12, 2025