AccessGUDID - DEVICE: Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal® (00817688024248)

GUDID

Device Identifier (DI) Information

Brand Name: Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal®
Version or Model: ICM-000-0710
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ICM-000-0710
Company Name: I.C. MEDICAL, INC.

Primary DI Number: 00817688024248
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 616182895 *Terms of Use

Device Description: Non-Telescopic PenEvac®-ST, MaxReveal ™ Diamond Crystal Blade®, 70mm (2.75in) Non-Stick Blade, 10 Foot Tube, 22mm to 10mm Connector and Holster, Sterile

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	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?
61869	Open-surgery electrosurgical handpiece/electrode, monopolar, single-use	A rigid device consisting of combined electrosurgical handpiece and monopolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a single-use device intended to be used in a sterile condition.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories

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
Storage Environment Temperature: between 0 and 140 Degrees Fahrenheit
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 17fbd27a-972a-4df8-91c3-f2b2d84041ab
Public Version Date: November 06, 2023
Public Version Number: 2
DI Record Publish Date: October 12, 2023