AccessGUDID - DEVICE: Key Surgical Vascular Loops (00849771030904)

GUDID

Device Identifier (DI) Information

Brand Name: Key Surgical Vascular Loops
Version or Model: VL-208
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: VL208
Company Name: KEY SURGICAL, INC.

Primary DI Number: 00849771030904
Issuing Agency: GS1
Commercial Distribution End Date: February 12, 2024
Device Count: 2
Labeler D-U-N-S® Number*: 604056226 *Terms of Use

Device Description: Vascular Loops, Sterile, White, Maxi, 18-inch long, 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 [?]
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
Length: 18 Inch

Device Record Status

Public Device Record Key: 74fd1675-64b3-42ee-ab58-850406af5dcb
Public Version Date: February 13, 2024
Public Version Number: 4
DI Record Publish Date: December 09, 2020