AccessGUDID - DEVICE: RetroPerc (00860000917506)

GUDID

Device Identifier (DI) Information

Brand Name: RetroPerc
Version or Model: RP91-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RP91-01
Company Name: RETROPERC INC.

Primary DI Number: 00860000917506
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 112165284 *Terms of Use

Device Description: Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set

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?
64235	Nephrostomy introduction sheath	A flexible or rigid tube intended to be inserted percutaneously into the renal pelvis to gain access to the upper urinary tract to maintain a nephrostomy tract for the introduction of other instruments (e.g., endoscope, guidewire, catheter); it is not a nephrostomy catheter. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LJE	Catheter, Nephrostomy

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
No Device Sizes

Device Record Status

Public Device Record Key: 645c5258-22dc-4be7-9945-b14bf191baf5
Public Version Date: January 17, 2025
Public Version Number: 1
DI Record Publish Date: January 09, 2025

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: 2489757372
Email: info@retroperc.com

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