AccessGUDID - DEVICE: PENADAPT (20845854053192)

GUDID

Device Identifier (DI) Information

Brand Name: PENADAPT
Version or Model: MEDLPA1025
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MEDLPA1025
Company Name: Conmed Corporation

Primary DI Number: 20845854053192
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 071595540 *Terms of Use
Previous DI: 00851136002624

Device Description: PENADAPT Electrosurgery Pencil adapter with 3/8" (.952 cm) x 1' (30.48 cm) tubing with 3/8" (.952 cm) to 3/8" (.952 cm) connector

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?
46483	Surgical plume evacuation system tube	A long, hollow cylinder which, as part of a surgical plume evacuation system, is intended to be used to capture, conduct, and exhaust the plume of smoke generated during open surgical procedures in which there is tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FYD	APPARATUS, EXHAUST, SURGICAL

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: No
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
No Device Sizes

Device Record Status

Public Device Record Key: 61586d78-41a1-4830-b51b-8e03c331d1f4
Public Version Date: August 13, 2024
Public Version Number: 3
DI Record Publish Date: September 17, 2020