AccessGUDID - DEVICE: Anmuth Medical International (08403207009975)

GUDID

Device Identifier (DI) Information

Brand Name: Anmuth Medical International
Version or Model: 39-537-17
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 39-537-17
Company Name: Anmuth Medical International, LLC

Primary DI Number: 08403207009975
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 786500830 *Terms of Use

Device Description: Flat nose pliers, 6.5", side cutting blades, tip tapers to 3.5mm

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?
32874	Wire holding/twisting pliers	A heavy-duty manual surgical instrument with specially-designed sturdy handles and blade jaws used to grip, tighten, and/or twist wires during a surgical intervention. It has a scissors-like design with curved handles and is made of high-grade stainless steel. It is available in various sizes and the jaws (typically short and broad with serrations) at the working end are activated through a single pivot or a double ratio-lever exchange pivot to provide greater gripping force. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	Orthopedic manual surgical instrument

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: 6.5 Inch

Device Record Status

Public Device Record Key: 5968f1a7-ddc7-406f-b836-68b5a31992dc
Public Version Date: June 13, 2025
Public Version Number: 1
DI Record Publish Date: June 05, 2025