AccessGUDID - DEVICE: NA (10888551007962)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: COOHDBF-2.4-230-S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: COOHDBF-2.4-230-S
Company Name: STERILMED, INC.

Primary DI Number: 10888551007962
Issuing Agency: GS1
Commercial Distribution End Date: February 14, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 175899459 *Terms of Use

Device Description: BIOPSY FORCEPS HOT CAPTURA 2.8MM WORKING CHANNEL (RED)

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?
42795	Female wearable urinal, reusable	A non-sterile, urine drainage device designed for women that typically consists of a flexible tube attached to a collector that is specially formed to securely fit around the female genitals to provide a route to channel urine, via a tube, into a collection bag. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NLU	FORCEPS, BIOPSY, ELECTRIC, REPROCESSED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K050136	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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: 911c2199-631f-47a0-ab70-460d758dda4a
Public Version Date: February 14, 2025
Public Version Number: 6
DI Record Publish Date: September 22, 2016