AccessGUDID - DEVICE: AESCULAP (04046964100673)

GUDID

Device Identifier (DI) Information

Brand Name: AESCULAP
Version or Model: PO830SU
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PO830SU
Company Name: Aesculap AG

Primary DI Number: 04046964100673
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 315018218 *Terms of Use

Device Description: METZENBAUM ADTEC SINGLE USE Dissecting Scissors, complete instrument, monopolar, curved to left, working length: 11 1/2", (290 mm),diam. 3,50 mm, rotatable, insulated, double action, sterile, disposable, package of 5 pieces

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:	Yes
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?
58039	Endoscopic electrosurgical handpiece/electrode, monopolar, single-use	A sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and may include a lumen for suction/irrigation; it requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and may be designed to also mechanically cut tissues. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, general & plastic surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Working length (mm) : 290.000 MM
Device Size Text, specify: Diameter (mm) : 3.500 MM

Device Record Status

Public Device Record Key: 3f862cdf-03dc-4321-83b9-e884e1f26a75
Public Version Date: January 18, 2022
Public Version Number: 8
DI Record Publish Date: October 10, 2016