AccessGUDID - DEVICE: PERCEVAL S (18022057015034)

GUDID

Device Identifier (DI) Information

Brand Name: PERCEVAL S
Version or Model: ICV1268
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: CORCYM SRL

Primary DI Number: 18022057015034
Issuing Agency: GS1
Commercial Distribution End Date: February 15, 2023
Device Count: 5
Labeler D-U-N-S® Number*: 441454802 *Terms of Use

Device Description: No description.

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":	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?
60835	Heart valve prosthesis holder safety clip	A sterile device intended to be attached to a heart valve prosthesis holder during open surgical implantation of a self-expandable heart valve bioprosthesis, to position, secure, and prevent accidental release of the heart valve prosthesis holderâ€™s holding mechanism (e.g., holding sheath). It is typically a plastic attachment with the appropriate size, shape and flexibility. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LWR	heart-valve, non-allograft tissue

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
No Device Sizes

Device Record Status

Public Device Record Key: 5b17950b-8d62-445a-93d6-0fc77196a517
Public Version Date: June 09, 2025
Public Version Number: 5
DI Record Publish Date: June 06, 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: 08022057015037 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

[?]

No Customer Contact currently defined

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