AccessGUDID - DEVICE: Porges Coloplast (03600040280508)

GUDID

Device Identifier (DI) Information

Brand Name: Porges Coloplast
Version or Model: ACXS12
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ACXS12
Company Name: Coloplast A/S

Primary DI Number: 03600040280508
Issuing Agency: GS1
Commercial Distribution End Date: July 10, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 305524696 *Terms of Use

Device Description: Ureteral Accesss Sheath 35cm

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):	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?
64309	Ureteral introduction sheath	A flexible tube intended to be used for ureteral access to allow introduction of other instruments (e.g., endoscope, catheter) and/or for guidewire exchange during a urological procedure. It may be intended for ureteral access via transurethral and/or percutaneous approach, and typically includes an inner dilator; it is however not a full introduction set. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FED	endoscopic access overtube, gastroenterology-urology

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
Special Storage Condition, Specify: Store away from light in a cool and dry place

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 12 French
Catheter Gauge: 14 French

Device Record Status

Public Device Record Key: f19d66bf-76e7-4778-b86b-dc84c5fa0b5d
Public Version Date: August 30, 2024
Public Version Number: 4
DI Record Publish Date: August 01, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)258-3476
Email: urology@coloplast.com

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