AccessGUDID - DEVICE: Clik-FIX (00850933007290)

GUDID

Device Identifier (DI) Information

Brand Name: Clik-FIX
Version or Model: FCS-1075
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FCS-1075
Company Name: STARBOARD MEDICAL, INC.

Primary DI Number: 00850933007290
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012983893 *Terms of Use

Device Description: Foley Catheter Securement device for 5-8 Fr.

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?
63012	Urinary catheter holder, sterile	A sterile device designed to be attached to a patient's body to hold an indwelling urinary catheter (e.g., Foley, ureteral), or a tube attached to it, in place. It typically consists of a wrap placed around the patient's thigh, abdomen, or pubis. The holder includes appropriate mechanisms or attachments that can hold the tube or catheter (e.g., integrated Velcro hook/loop closure, spring tensioner) without creating excessive pressure on it and permitting visual inspection of the site. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EYJ	Holder, Ureteral Catheter

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: c22748b9-a78c-4a2d-9427-f58f156ce8f2
Public Version Date: April 26, 2019
Public Version Number: 1
DI Record Publish Date: April 18, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10850933007297	50	00850933007290		In Commercial Distribution	Box

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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