AccessGUDID - DEVICE: AESCULAP (04038653049974)

GUDID

Device Identifier (DI) Information

Brand Name: AESCULAP
Version or Model: LX150R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LX150R
Company Name: Aesculap AG

Primary DI Number: 04038653049974
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315018218 *Terms of Use

Device Description: TC Wire Cutting Forceps, 5 3/4", (145 mm), special hardened cutting edges, hard wire up to Ø 1.5 mm, soft wire up to Ø 2.0 mm, non-sterile, reusable

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?
44805	Orthopaedic implantable-device cutter	A heavy-duty manual surgical instrument designed to hold and cut orthopaedic surgical implant devices (i.e., metal rods, plates, screws). The cutting is typically performed with a shearing action. It may be a hand-held or a table mounted device. 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: d777c8dd-783d-4971-8387-f994f48430fc
Public Version Date: February 17, 2025
Public Version Number: 2
DI Record Publish Date: May 06, 2020