FDA UDI
In Commercial Distribution
🇺🇸 United States
Zipshield 5m
DI: 00850011306963
·
Model: 5m
·
NEURALYNX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Zipshield 5m
- Primary DI
- 00850011306963
- Version / Model
- 5m
- Catalog Number
- 31-0604-0128
- Company Name
- NEURALYNX, INC.
- Labeler DUNS
- 933200842
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-11
- Public Version
- 1
- Public Version Date
- 2024-12-19
- Public Version Status
- New
- Public Device Record Key
- 015932db-c4ff-467a-a099-0352ce01faa7
Device Description
This product contains a full conductive metal plated cloth inner shield with a durable plastic outer jacket which is easily applied over one or more ATLAS Tether cables providing both noise shielding and cable management.
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
- 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 |
|---|---|---|---|---|
| OMC | Reduced- Montage Standard Electroencephalograph | Neurology | 882.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38370 | Facility radio-frequency shielding material | A radiation protection device consisting of electrically conductive materials used in conjunction with other medical devices in a medical facility to form a barrier against radio-frequency (RF) emissions and interference. This kind of material protects medical devices and/or persons from incident or stray radio-frequency fields. This group of devices includes a wide variety of materials, e.g., copper (Cu) sheeting and copper mesh. Copper sheets and copper mesh are used in walls, floors, ceiling, doors and windows for magnetic resonance imaging rooms to prevent interference with the electronics used to form and receive the radio-frequency imaging pulses. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850011306963 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K110967 | 000 |