FDA UDI
In Commercial Distribution
🇺🇸 United States
HFD100
DI: 00857534006592
·
Model: 119629-000
·
IMRIS Imaging, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- HFD100
- Primary DI
- 00857534006592
- Version / Model
- 119629-000
- Company Name
- IMRIS Imaging, Inc.
- Labeler DUNS
- 079990922
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-04
- Public Version
- 2
- Public Version Date
- 2025-04-08
- Public Version Status
- Update
- Public Device Record Key
- eac5cac3-4f54-4d30-833f-71c32240c6b7
Device Description
Head Fixation Device HFD100 -ORT 400 IMPERIAL
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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | Neurology | 882.4460 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35446 | Skull clamp | A U-shaped surgical device intended to hold the head and neck in a particular fixed position during surgical procedures. It is connected to the skull with screws or pins (not included), typically on each side of the forehead, whilst the other end is fixed to an operating table or chair. Commonly known as a Mayfield skull clamp, it is made of metal materials (non-radiolucent) and may have adjustable joints (either incorporated or separate) for positioning/stabilization; it is not intended for applying traction forces to the cervical spine. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857534006592 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K103493 | 000 |