AccessGUDID - DEVICE: PERCUVANCE (14026704640208)

GUDID

Device Identifier (DI) Information

Brand Name: PERCUVANCE
Version or Model: IPN029181
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PCVSB12
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 14026704640208
Issuing Agency: GS1
Commercial Distribution End Date: June 15, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 14026704582881

Device Description: 12 MILLIMETER SEAL BRIDGE

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?
45597	Laparoscopic access cannula seal reducer, single-use	A small device intended to reduce the sealing diameter of an existing laparoscopic access cannula seal, so laparoscopic instruments with smaller diameters can be introduced through the parent laparoscopic sleeve whilst maintaining a seal and inhibiting the leakage of insufflation media [e.g., carbon dioxide (CO2) gas]. It is intended to fit within the laparoscopic access cannula seal (fitted at the proximal end of the cannula) when required throughout the laparoscopic surgical procedure. 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 [?]
K181852	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
Length: 3.4 Inch
Width: 0.7 Inch

Device Record Status

Public Device Record Key: 620c53f5-5010-4845-9658-db3788171963
Public Version Date: July 25, 2024
Public Version Number: 6
DI Record Publish Date: October 22, 2018