AccessGUDID - DEVICE: NA (00724995157845)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: BF186
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: BF186
Company Name: STERIS CORPORATION

Primary DI Number: 00724995157845
Issuing Agency: GS1
Commercial Distribution End Date: January 13, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 036985604 *Terms of Use

Device Description: The Drain Pan attaches to the perineal edge of the seat section of the table, the IA Extender, or the 9 inch Urology Extension.

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
56731	Surgical tissue/fluid collection bag	A flexible container (a pouch) designed to be attached adjacent to a site of surgical intervention to collect and store body fluids, tissue, or body parts (e.g., a limb) released during the procedure. It is typically constructed as a pouch made of plastic foils with an adhesive band for attachment (e.g., next to the patient's skin incision or on the sterile drape), is available in a variety of sizes, and may be equipped with a fluid filter. This device is not intended to connect to an active drainage system or suction system but relies on gravity for fluid collection. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQO	TABLE, OPERATING-ROOM, AC-POWERED

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: No
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
No Device Sizes

Device Record Status

Public Device Record Key: b0cd1115-9f53-4be9-82cd-4753d83318eb
Public Version Date: January 23, 2025
Public Version Number: 3
DI Record Publish Date: April 23, 2021