AccessGUDID - DEVICE: ClearFit (00855113008043)

GUDID

Device Identifier (DI) Information

Brand Name: ClearFit
Version or Model: 171714
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 171714
Company Name: LONGEVITI NEURO SOLUTIONS LLC

Primary DI Number: 00855113008043
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070659539 *Terms of Use

Device Description: Complex Static Cranial Implant (Primary and Backup)

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):	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?
16131	Cranial resinous compound	A substance used to reconstitute cranial bone after neurosurgery (i.e., cranioplasty). It typically consists of a self-curing resin [e.g., polymethylmethacrylate (PMMA)] or a two part resinous material made of several compositions. It may be conformed as an inert implant in an appropriate shape (e.g., a plate) needed to repair the defect of the skull, either using an intraoperatively cured solid composition, or a preoperatively fabricated, porous, custom-made, implant. After application, this device cannot be reused.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GXN	Plate, Cranioplasty, Preformed, Non-Alterable
PJN	Filler, Bone Void, Non-Alterable Compound For Cranioplasty

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170410	000

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
Special Storage Condition, Specify: See special handling instructions
Handling Environment Temperature: between 59 and 86 Percent (%) Relative Humidity
Storage Environment Humidity: between 0 and 70 Percent (%) Relative Humidity
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Area/Surface Area: 60 Square centimeter

Device Record Status

Public Device Record Key: 0546b7b3-13e2-4709-99bb-62b4102f3d07
Public Version Date: December 24, 2018
Public Version Number: 1
DI Record Publish Date: November 21, 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
10855113008040	2	00855113008043		In Commercial Distribution	Case

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: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 410-527-1803
Email: info@longeviti.com

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