AccessGUDID - DEVICE: EPITOME (H671CBE2600)

GUDID

Device Identifier (DI) Information

Brand Name: EPITOME
Version or Model: Epitome .2 with ZapGuard
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CBE-260
Company Name: UTAH MEDICAL PRODUCTS, INC.

Primary DI Number: H671CBE2600
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 094651270 *Terms of Use

Device Description: Disposable Electrosurgical Electrode with ZapGuard, 0.16" (4mm) Blade Length, 4" (10cm) Bendable Shaft Length, 0.2mm Wire Diameter

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:	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?
61874	Open-surgery electrosurgical electrode, monopolar, single-use	An invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Wire Diameter - 0.2 mm
Device Size Text, specify: Shaft Length - 4" (10cm)
Device Size Text, specify: Blade Length - 0.16" (4mm)

Device Record Status

Public Device Record Key: c151144d-a27f-4948-9314-cc14af1bd52d
Public Version Date: December 18, 2019
Public Version Number: 4
DI Record Publish Date: September 23, 2016