AccessGUDID - DEVICE: NA (00849771050544)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: Vascular Loops
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VL201
Company Name: KEY SURGICAL, INC.

Primary DI Number: 00849771050544
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 604056226 *Terms of Use
Previous DI: 00849771030836

Device Description: Vascular Loops, Sterile, Red, Mini, 2 per package

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
61916	Surgical vessel loop	A nonimplantable cord intended to be used during a surgical procedure to assist a surgeon to identify, retract and occlude blood vessels, tendons and nerves. It is constructed of synthetic polymer and is typically coloured to facilitate visualization. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDC	INSTRUMENT, SURGICAL, DISPOSABLE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K896676	000

Device Exempt from Premarket Submission: No 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
Device Size Text, specify: Diameter Cross Section 1.3mm x 0.9mm
Length: 18 Inch

Device Record Status

Public Device Record Key: 0d51aa98-4358-4a5d-80c3-b6e38eea8e16
Public Version Date: March 19, 2024
Public Version Number: 1
DI Record Publish Date: March 11, 2024