FDA UDI
In Commercial Distribution
🇺🇸 United States
Ambu Concentric ProbeSingle Patient Probes
DI: 05707480108558
·
Model: 73603-190/10
·
Ambu A/S
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Ambu Concentric ProbeSingle Patient Probes
- Primary DI
- 05707480108558
- Version / Model
- 73603-190/10
- Catalog Number
- 73603-190/10
- Company Name
- Ambu A/S
- Labeler DUNS
- 305682023
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 4
- Public Version Date
- 2026-01-30
- Public Version Status
- Update
- Public Device Record Key
- 87cbf98c-5aea-4b88-9fc4-f06a50d8881d
Device Description
Ambu Disposable IOM Stimulation Probes 100 mm long Concentric with 1,5 mm connector and 1,9 m. attached cable 10 probes per box = min. sale
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GXZ | ELECTRODE, NEEDLE | Neurology | 882.1350 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11441 | Electromyographic needle electrode, single-use | A sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05707480108565 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 05707480108558 | GS1 | ||||
| Package | 05707480108688 | GS1 | 34 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(410)768-6464
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 100 | Millimeter | |
| Length | 190 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius