AccessGUDID - DEVICE: Anmuth Medical International (08403207190123)

GUDID

Device Identifier (DI) Information

Brand Name: Anmuth Medical International
Version or Model: 14-104-13
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 14-104-13
Company Name: Anmuth Medical International, LLC

Primary DI Number: 08403207190123
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 786500830 *Terms of Use

Device Description: USA Dressing Forceps 13cm/5"

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?
42500	Dressing/utility forceps, tweezers-like, reusable	A hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It typically has a tweezers-like design with two blades joined at the proximal (non-working) end with variously designed tips at the working end. It is made of metal and/or plastic materials and is available in various sizes. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTD	FORCEPS

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: 5 Inch

Device Record Status

Public Device Record Key: fd8273b7-bd17-48a8-9484-bc91cf34c29a
Public Version Date: April 18, 2024
Public Version Number: 1
DI Record Publish Date: April 10, 2024