AccessGUDID - DEVICE: Clarren Helmet (B15170405A0)

GUDID

Device Identifier (DI) Information

Brand Name: Clarren Helmet
Version or Model: 704.05A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 704.05A
Company Name: ORTHOMERICA PRODUCTS, INC.

Primary DI Number: B15170405A0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 604405373 *Terms of Use

Device Description: The Clarren Helmet is a patient specific cranial orthosis that applies passive pressure to prominent regions of an infant’s cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic, and scaphocephalic- shaped heads. The Clarren Helmet is made with an outer polypropylene plastic shell with a Plastizote inner liner and a chinstrap to help hold the helmet in place.

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?
62265	Cranial orthosis	A custom-made helmet-like device intended to be worn on the head of an infant with an abnormal head shape (e.g., due to plagiocephaly, brachycephaly, scaphocephaly), or after craniosynostosis repair surgery, to apply pressure to the cranium and improve cranial symmetry/shape during growth over a period of months. It is made of durable materials (e.g., plastic, solid foam) and is designed with patient-specific characteristics (e.g., size, shape) based on head measurements (e.g., clinical pictures, 3-D scans, casts). It is typically worn during daily activities and sleep. This is a single-patient device that can be reapplied during the treatment period (reusable) before being discarded.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVA	Orthosis, Cranial

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K021918	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
No Device Sizes

Device Record Status

Public Device Record Key: e4414068-1a8b-4973-9a8d-e080bb52e5e4
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 22, 2016