AccessGUDID - DEVICE: Liquimark (B971LM31)

GUDID

Device Identifier (DI) Information

Brand Name: Liquimark
Version or Model: LiquiMark 30mm tube MRI marker
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Jessop Precision Products Inc.

Primary DI Number: B971LM31
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 40
Labeler D-U-N-S® Number*: 055127831 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	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?
61577	Skin marking sticker	A hypoallergenic adhesive device (sticker) intended to be affixed to a patient’s skin (e.g., forehead) as a point of reference (marker), typically for use with external diagnostic imaging techniques. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JAC	System, X-Ray, Film Marking, Radiographic

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: c7c57a6d-268e-49a4-a3f4-12df661a9b7d
Public Version Date: October 18, 2021
Public Version Number: 1
DI Record Publish Date: October 08, 2021