UDI device identifier
iTalk4 10000028
UDI device identifier 00186648000531 · Ablenet, Inc.
Key facts
| Primary DI | 00186648000531 |
|---|---|
| Brand name | iTalk4 |
| Version or model | 10000028 |
| Catalog number | 10000028 |
| Company | Ablenet, Inc. |
| DUNS number | 791664543 |
| Product code | ILQ |
| GMDN term | Assistive speech generator |
| Device class | Class II |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Jun 21, 2023 |
| Version date | Jun 29, 2023 |
| Description | The easiest way to provide an individual with four side-by-side communication choices is with the iTalk4 speech device. Activate the colored top to play the desired message. New messages are easily and quickly recorded to the iTalk4 on the fly, or use the levels pre-record up to three sets of… |
At a glance
- None MAUDE reports citing this UDI
- No Linked premarket submission
- Yes EUDAMED counterpart found
- 1,000+ GUDID devices with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About UDI device identifiers (GUDID)
The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.
Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date: