AccessGUDID - DEVICE: Eclipse (00815430020678)

GUDID

Device Identifier (DI) Information

Brand Name: Eclipse
Version or Model: SZ02
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SZ02-64EP
Company Name: CLINICAL INNOVATIONS, LLC

Primary DI Number: 00815430020678
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 809524291 *Terms of Use

Device Description: Sizer with RFID Direct Marking

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
62321	Faecal-incontinence vaginal insert sizer	A non-sterile device intended to be used to determine the appropriate size of a faecal-incontinence vaginal insert for a particular patient. It is in the form of a semi-rigid ring that is inserted into the vagina as a guide to the size of the trial/final insert. It is intended to be used by a healthcare professional in a clinical setting. This is a reusable device for multi-patient use after appropriate cleaning/disinfection.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PJH	Dynamic Rectal Control System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150558	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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
Width: 64 Millimeter
Length: 70 Millimeter

Device Record Status

Public Device Record Key: 4d7e706f-b82e-4284-8496-eb3be03810b9
Public Version Date: February 06, 2023
Public Version Number: 3
DI Record Publish Date: September 11, 2018

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: 844-668-6225
Email: cs@pelvalon.com

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