FDA UDI
In Commercial Distribution
🇺🇸 United States
Hanger Cranial Band 3D
DI: 00859065006027
·
Model: A8210
·
Symbiont Logistics, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Hanger Cranial Band 3D
- Primary DI
- 00859065006027
- Version / Model
- A8210
- Company Name
- Symbiont Logistics, LLC
- Labeler DUNS
- 117545164
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-26
- Public Version
- 1
- Public Version Date
- 2025-01-03
- Public Version Status
- New
- Public Device Record Key
- 6ef9b51f-04b0-430c-8dca-2b576a499087
Device Description
Cranial Remolding Orthosis
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MVA | Orthosis, Cranial | Neurology | 882.5970 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859065006027 | GS1 |