AccessGUDID - DEVICE: kinderBAND (00863457000302)

GUDID

Device Identifier (DI) Information

Brand Name: kinderBAND
Version or Model: CL-4000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CL-4000
Company Name: BIOSCULPTOR CORPORATION

Primary DI Number: 00863457000302
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 926813379 *Terms of Use

Device Description: The kinderBAND™ cranial remolding orthosis is a custom made orthotic device available by prescription only. It is used to treat infants between 3 and 18 months of age for asymmetrical head shapes such as positional plagiocephaly, brachycephaly and scaphocephaly.

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):	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
OAN	Orthosis, Cranial, Laser Scan

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K081787	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: 183677cf-dc86-43f4-9f0c-01cad1174027
Public Version Date: June 13, 2023
Public Version Number: 4
DI Record Publish Date: October 03, 2016