AccessGUDID - DEVICE: ImaJin (05708932059428)

GUDID

Device Identifier (DI) Information

Brand Name: ImaJin
Version or Model: AJ4U75
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AJ4U75
Company Name: Coloplast A/S

Primary DI Number: 05708932059428
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305524696 *Terms of Use

Device Description: ImaJin ImaJin™. iso. Double loop ureteral stent kit. without eye on the straight section. Length 28 cm, Catheter Gauge 7 FR/CH.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
60755	Urological surgical procedure kit, non-medicated, single-use	A collection of various urological surgical instruments and the necessary materials intended to be used during a urological surgical/endoscopic procedure; it is not a dedicated bladder irrigation set. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of urological surgical procedure, but are often supplied together to perform a specific type of urological procedure; it does not contain any pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FAD	Stent, ureteral

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Catheter Gauge: 7 French
Length: 28 Centimeter

Device Record Status

Public Device Record Key: 458fae7b-0680-4bd7-96ba-7fe805508a4c
Public Version Date: September 14, 2023
Public Version Number: 2
DI Record Publish Date: November 14, 2022