AccessGUDID - DEVICE: WIKI Drain, 15 Fr, 3 cm, 6 Drains (00861838000347)

GUDID

Device Identifier (DI) Information

Brand Name: WIKI Drain, 15 Fr, 3 cm, 6 Drains
Version or Model: WIK-15-3-6
Commercial Distribution Status: In Commercial Distribution
Catalog Number: WIK-15-3-6
Company Name: TOOLS FOR SURGERY, LLC

Primary DI Number: 00861838000347
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 841842441 *Terms of Use

Device Description: The WIKI Drain is a flanged quadruple-lumen silicone channel drain. Package contains 6, 15 Fr, 3 cm drains.

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?
38566	Surgical capillary wound drain, non-luminal	A sterile device, without a lumen, designed to establish a passive egress for the removal of fluid (drainage of blood, lymph, exudate) from a surgical wound to minimize its accumulation and risk of wound infection; it is not dedicated to a particular anatomical wound. It is typically inserted into the wound by a surgeon in the operating room (OR) after the completion of an inpatient or outpatient procedure. It is typically available as a corrugated drainage sheet or ribbon made of non-latex materials [e.g., polyvinyl chloride (PVC), silicone], and may include radiopaque markers. 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 5 Millimeter
Length: 3 Centimeter

Device Record Status

Public Device Record Key: 660bf5cb-f7a6-4311-b65e-346b7ac0a2e8
Public Version Date: July 25, 2023
Public Version Number: 1
DI Record Publish Date: July 17, 2023