AccessGUDID - DEVICE: Irrigation Syringe Attachment (00861361000234)

GUDID

Device Identifier (DI) Information

Brand Name: Irrigation Syringe Attachment
Version or Model: 1.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ISA-001
Company Name: Biorep Technologies, Inc.

Primary DI Number: 00861361000234
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 073724333 *Terms of Use

Device Description: The Irrigating Syringe Attachment is a device that enables a patient to perform self-irrigation of tunneling wounds. The device is comprised of a Luer slip elbow connector irrigation port with removable Luer cap, a rotatable manifold, and multiple irrigation tubes each with a slidable (repositionable) tapered tip with wings

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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":	Yes
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?
35390	Irrigation syringe	A general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KYZ	Syringe, Irrigating (Non Dental)

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: 2aef0a1e-ead2-4552-8585-d9a402873841
Public Version Date: February 24, 2025
Public Version Number: 1
DI Record Publish Date: February 14, 2025