Identity
- Trade Name
- kinderBAND FDA UDI
- Generic Name
- Cranial orthosis FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- CL-4000 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- CL-4000 FDA UDI
- Primary DI / UDI-DI
- 00863457000302 FDA UDI
- 510(k) Number
- K081787 FDA UDI
- FDA Product Code
- MVA FDA UDIOAN FDA UDI
- GMDN Term
- Cranial orthosis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5970 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cranial orthosis
kinderBAND by BioSculptor Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cranial orthosis.
- STARband® 3D — ORTHOMERICA PRODUCTS, INC. · Class II
- STARband® Bi-Valve — ORTHOMERICA PRODUCTS, INC. · Class II
- STARlight® — ORTHOMERICA PRODUCTS, INC. · Class II
- STARband® Plus — ORTHOMERICA PRODUCTS, INC. · Class II
- STARband® Bi-Valve — ORTHOMERICA PRODUCTS, INC. · Class II
- STARlight® PRO — ORTHOMERICA PRODUCTS, INC. · Class II
- STARlight® PRO — ORTHOMERICA PRODUCTS, INC. · Class II
- STARband® Plus — ORTHOMERICA PRODUCTS, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BioSculptor Corporation
Sources (1)
- FDA UDI 183677cf-dc86-43f4-9f0c-01cad1174027 36 fields · synced Jun 9, 2026