AccessGUDID - DEVICE: Codman VersaTru™ (10381780521570)

GUDID

Device Identifier (DI) Information

Brand Name: Codman VersaTru™
Version or Model: 9008150SL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9008150SL
Company Name: Integra LifeSciences Switzerland Sàrl

Primary DI Number: 10381780521570
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480186617 *Terms of Use
Previous DI: 10886704080022

Device Description: CODMAN VersaTru™ Slim Disposable Non-Stick Bipolar Forceps 8" (20cm), 1.5mm Tip

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?
56296	Open-surgery electrosurgical handpiece/electrode, bipolar, single-use	A sterile rigid combined electrosurgical handpiece and bipolar 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, cutting & coagulation & accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162469	000

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
Special Storage Condition, Specify: Do Not Use if Package is Damaged
Storage Environment Atmospheric Pressure: between 50 and 105 KiloPascal
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 50 and 105 KiloPascal
Handling Environment Temperature: between 20 and 80 Degrees Fahrenheit
Storage Environment Temperature: between -20 and 50 Degrees Celsius
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 20 and 80 Degrees Fahrenheit
Handling Environment Temperature: between -20 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 8 Inch
Device Size Text, specify: 1.5 mm Tip

Device Record Status

Public Device Record Key: 3b6435dd-aa2e-4ef1-8e69-cbbe004b41d7
Public Version Date: May 16, 2023
Public Version Number: 5
DI Record Publish Date: June 02, 2020