AccessGUDID - DEVICE: PERL Localization Device, 16Ga x 11.5cm Needle (00851766006245)

GUDID

Device Identifier (DI) Information

Brand Name: PERL Localization Device, 16Ga x 11.5cm Needle
Version or Model: R10
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: FOCAL THERAPEUTICS, INC.

Primary DI Number: 00851766006245
Issuing Agency: GS1
Commercial Distribution End Date: November 16, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 965352946 *Terms of Use

Device Description: PERL Localization Device, 16Ga x 11.5cm Needle

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
40808	Radiological image marker, implantable	A device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GDF	Guide, Needle, Surgical

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
Device Size Text, specify: Needle Length: 11.5cm
Device Size Text, specify: Ring Diameter: 1.0cm
Needle Gauge: 16 Gauge

Device Record Status

Public Device Record Key: 5483b58e-b0cd-401a-8505-1a8216b99427
Public Version Date: February 12, 2024
Public Version Number: 5
DI Record Publish Date: July 16, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10851766006242	5	00851766006245	2021-11-16	Not in Commercial Distribution	Shelf Carton, 5up
20851766006249	1	00851766006245	2021-11-16	Not in Commercial Distribution	Shelf Carton, 1up