AccessGUDID - DEVICE: PERCEVAL S (08022057014917)

GUDID

Device Identifier (DI) Information

Brand Name: PERCEVAL S
Version or Model: ICV1232
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CORCYM SRL

Primary DI Number: 08022057014917
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
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:	No
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?
58736	Self-expandable heart valve prosthesis collapsing tool base	A plate-like device designed to function as a sturdy support (base) for a self-expanding cardiac valve prosthesis collapsing tool during the procedure where the tool is used to reduce the diameter of a self-expanding cardiac valve prosthesis to facilitate its implantation. It typically consists of a stainless steel plate-like base with holes and slots for attachment of the collapsing tool, and supports for alignment of the valve holder. This is a reusable device intended to be sterilized prior to use.	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 [?]
P150011	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 98267b8a-9da3-45b3-bce8-42293bbbe3c9
Public Version Date: February 08, 2023
Public Version Number: 4
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: 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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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