AccessGUDID - DEVICE: PERCUVANCE (14026704582935)

GUDID

Device Identifier (DI) Information

Brand Name: PERCUVANCE
Version or Model: IPN027882
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PCVSPT5
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 14026704582935
Issuing Agency: GS1
Commercial Distribution End Date: June 15, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: 5 MILLIMETER Spatula Cautery 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?
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 [?]
K153063	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
Storage Environment Temperature: between 16 and 37 Degrees Celsius
Handling Environment Temperature: between -29 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Width: 0.22 Inch
Depth: 0.22 Inch
Length: 2.5 Inch

Device Record Status

Public Device Record Key: 0d56d8a3-9af6-4ead-99f3-ffdbf3e1e1df
Public Version Date: June 16, 2021
Public Version Number: 9
DI Record Publish Date: April 20, 2018