AccessGUDID - DEVICE: Round Drain type Jackson-Pratt w/trocar Fr 10 (08034139294650)

GUDID

Device Identifier (DI) Information

Brand Name: Round Drain type Jackson-Pratt w/trocar Fr 10
Version or Model: 24211
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 24211
Company Name: REDAX SPA

Primary DI Number: 08034139294650
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338664915 *Terms of Use

Device Description: The surgical drainage is a sterile and single-use device. The drainage has depth markings, graduated from the end of the perforated section: these markings facilitate accurate positioning of the drainage in the wound. The drainage is biocompatible and hemocompatible (in accordance with the regulations in force). The product is compatible for use with gravity or suction drainage systems.

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?
11305	Closed-wound drain, non-bioabsorbable	A tube-like, non-bioabsorbable device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp trocar blade, connector), however it does not include any fluid collection bags/containers. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GBX	Catheter, Irrigation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f2ac0eb2-bb11-417e-b580-b3daaa6018aa
Public Version Date: March 08, 2022
Public Version Number: 2
DI Record Publish Date: May 07, 2021