FDA.reportPublic FDA data

Paradigm

Primary DI
00842318106575
Brand
Paradigm
Company
Starkey Laboratories, Inc.
Model
Surflink Programmer
Catalog number
60007-000
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OSMHearing aid, air conduction with wireless technology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842318106575PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842318106575008423181065758423181065750842318106575

GMDN Terms#

Term, Definition table
TermDefinition
Hearing aid wireless-fitting computer-aided setA collection of devices designed to work in conjunction with a computer to transmit wireless data to a hearing aid for computer-aided adjustment of the hearing aid while it is being fitted to a patient by healthcare personnel. It primarily consists of computer application software and a neck loop to establish the wireless link (the radio link protocol) with the hearing aid. The hearing aid must be compatible for wireless data reception and may be behind-the-ear (BTE), in-the-ear (ITE) and completely-in-the-canal (CIC) types.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
055461479
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840388213773OUIEZENOuieZen SL2 Charger RIC R/RT 2026-02-13
00840388213780OUIEZENOuieZen SL2 Prm Charger RIC R/RT2026-02-13
00840388213797NUEARNUEAR NE SERIES AI P BTE 132026-02-13
00840388213803NUEARNUEAR NE SERIES AI UP BTE 132026-02-13
00840388207161KINDKINDviano 3 RIC R2026-02-11
00840388210024OUIEZENOuieZen 24 OM CIC2026-02-11
00840388210246OUIEZENOuieZen 16 OM CIC2026-02-11
00840388210505OUIEZENOuieZen 16 OM mRIC R2026-02-11
00840388211908STARKEYStarkey G Series AI 24 UP BTE 132026-02-08
00840388211915STARKEYStarkey G Series AI 20 UP BTE 132026-02-08
00840388211922STARKEYStarkey G Series AI 16 UP BTE 132026-02-08
00840388211939STARKEYStarkey G Series AI 12 UP BTE 132026-02-08
00840388211946STARKEYStarkey G Series AI 10 UP BTE 132026-02-08
00840388211953STARKEYStarkey G Series AI UP BTE 132026-02-08
00840388211960STARKEYStarkey G Series AI 24 UP BTE 13 (DEMO)2026-02-08
00840388211977STARKEYStarkey G Series AI UP BTE 13 (TIER DEMO)2026-02-08
00840388211991STARKEYStarkey G Series AI 24 UP BTE 13 (GS DEMO)2026-02-08
00840388212004AUDIBELAudibel A Series AI 24 UP BTE 132026-02-08
00840388212011AUDIBELAudibel A Series AI 20 UP BTE 132026-02-08
00840388212028AUDIBELAudibel A Series AI 16 UP BTE 132026-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613275596814PhonakSonova AGOSM2018-02-28
07613275596845PhonakSonova AGOSM2018-02-28
07613275596869PhonakSonova AGOSM2018-02-28
07613275596883PhonakSonova AGOSM2018-02-28
07613275596944PhonakSonova AGOSM2018-02-28
07613275596951PhonakSonova AGOSM2018-02-28
07613275596968PhonakSonova AGOSM2018-02-28
07613275596982PhonakSonova AGOSM2018-02-28
07613275596999PhonakSonova AGOSM2018-02-28
07613275597002PhonakSonova AGOSM2018-02-28
07613275597019PhonakSonova AGOSM2018-02-28
07613275597033PhonakSonova AGOSM2018-02-28
07613275601327PhonakSonova AGOSM2018-02-28
07613275601402PhonakSonova AGOSM2018-02-28
07613275601426PhonakSonova AGOSM2018-02-28
07613275601501PhonakSonova AGOSM2018-02-28
07613275601518PhonakSonova AGOSM2018-02-28
07613275601556PhonakSonova AGOSM2018-02-28
07613275601594PhonakSonova AGOSM2018-02-28
07613275601600PhonakSonova AGOSM2018-02-28
07613275601655PhonakSonova AGOSM2018-02-28
07613275601662PhonakSonova AGOSM2018-02-28
07613275601686PhonakSonova AGOSM2018-02-28
07613275601693PhonakSonova AGOSM2018-02-28
07613275602935PhonakSonova AGOSM2018-02-28
07613275602959PhonakSonova AGOSM2018-02-28
07613275603000PhonakSonova AGOSM2018-02-28
07613275603017PhonakSonova AGOSM2018-02-28
07613275603048PhonakSonova AGOSM2018-02-28
07613275603062PhonakSonova AGOSM2018-02-28