AccessGUDID - DEVICE: SCHWERT (E8965000490)

GUDID

Device Identifier (DI) Information

Brand Name: SCHWERT
Version or Model: 5000-49
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5000-49
Company Name: A. Schweickhardt GmbH & Co. KG

Primary DI Number: E8965000490
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341195628 *Terms of Use

Device Description: Ligature cutting pliers 11 cm, with hard steel inserts for soft wire up to 0,4m /.016"

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:	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?
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
HXZ	CUTTER, WIRE

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
No Device Sizes

Device Record Status

Public Device Record Key: e9900aae-ad79-4cc5-a8d7-2244394d2dbe
Public Version Date: April 15, 2025
Public Version Number: 1
DI Record Publish Date: April 07, 2025