FDA.reportPublic FDA data

Lightwriter

Primary DI
07340023111042
Brand
Lightwriter
Company
Abilia AB
Model
SL50
Catalog number
1740500
Device description
Lightwriter SL50
Published
2021-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILQSystem, Communication, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILQSystem, Communication, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07340023111042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07340023111042073400231110427340023111042

GMDN Terms#

Term, Definition table
TermDefinition
Voice synthesizer/digitizerAn assistive device designed to deliver voice output based either in the reproduction of previously-recorded natural speech and/or on an electronic synthesized voice following a pre-established set of pronunciation rules. It typically consists of an electronic unit with a keyboard and screen; the keyboard may include letters, symbols, or both. The device is often customized to meet the user?s needs and is mostly used by patients with disabilities that partially or totally impair voice capabilities, including chronic progressive diseases.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+46859469400info@abilia.se

Regulatory Flags#

DUNS number
354656621
Device count
1
Premarket exempt
true
Serial number
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840828196468RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-05-27
G783OSKOL20IrisbondIRISBOND CROWDBONDING SL.ILQ2025-08-01
00812324010319Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010326Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010333Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010340Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010357Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010364Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010371Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010388Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010395Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010401Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010418Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010425Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010432Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010449Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010456Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010463Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010470Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010487Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010494Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010500Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010517Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010524Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010531Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010548Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010555Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010562Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010579Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010586Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13