Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Also covers the following minor/medium updates: v3.1.0 (01)00860001471724(11)210526(10)310; v3.1.1 (01)00860001471724(11)210604(10)311; v3.1.2 (01)00860001471724(11)210625(10)312; v3.2.0 (01)00860001471724(11)210713(10)320; v3.2.1. (01)00860001471724(11)210804(10)321; v3.2.2 (01)00860001471724(11)210917(10)322; v3.2.3 (01)00860001471724(11)211026(10)323 ;v3.2.4 (01)00860001471724(11)211123(10)324; v3.7.0 (01)00860001471724(11) 221116(10)370; v3.6.2 (01)00860001471724(11) 221024(10)362; v3.4.0:(01)00860001471724(11)220609(10)350; v3.5.1(01)00860001471724(11)220718(10)351; v3.6.0 (01)00860001471724(11) 220926(10)360; v3.8.0 (01)00860001471724(11) 221215(10)380; v3.8.1 (01)00860001471724(11) 230127(10)381; v3.9.0 (01)00860001471724(11) 230217(10)390; v3.9.1 (01)00860001471724(11) 230417(10)391; v3.9.2 (01)00860001471724(11) 230609(10)392; v3.9.3 (01)00860001471724(11) 230714(10)393; v3.10.0 (01)00860001471724(11) 231013(10)3100
AMPLIFON SPA
iOS v3
In Commercial Distribution

  • 00860001471724 ()


  • Hearing aid/implant system remote control
App Android 2.0.1. This database entry also covers the following minor/medium software updates: v2.0.2: (01)00860001471717(11)190807(10)202; v2.0.3: (01)00860001471717(11)190927(10)203; v2.0.4: (01)00860001471717(11)191014(10)204; v2.0.5: (01)00860001471717(11)191218(10)205; v2.0.6: (01)00860001471717(11)200227(10)206; v2.1.0: (01)00860001471717(11)200420(10)210; v2.2.1: (01)00860001471717(11)200729(10)221; v2.3.0: (01)00860001471717(11)201217(10)230; v2.3.1: (01)00860001471717(11)210205(10)231; v2.3.2: (01)00860001471717(11)210507(10)232
AMPLIFON SPA
2.0.1
In Commercial Distribution

  • 00860001471717 ()


  • Hearing aid/implant system remote control
App IOS 2.0.1. This database entry also covers the following minor/medium software updates: v2.0.2: (01)00860001471700(11)190807(10)202; v2.0.3: (01)00860001471700(11)190927(10)203; v2.0.4: (01)00860001471700(11)191014(10)204; v2.0.5: (01)00860001471700(11)191218(10)205; v2.0.6:(01)00860001471700(11)200227(10)206; v2.1.0: (01)00860001471700(11)200528(10)210; v2.2.1: (01)00860001471700(11)200729(10)221; v2.3.0: (01)00860001471700(11)201217(10)230; v2.3.1: (01)00860001471700(11)210205(10)231; v2.3.2: (01)00860001471700(11)210507(10)232
AMPLIFON SPA
2.0.1
In Commercial Distribution

  • 00860001471700 ()


  • Hearing aid/implant system remote control
Reusable SpO2 Sensor/超思/Soft Tip/Adult/3.0M/LP6
Unimed Medical Supplies, Inc.
U410S-96
In Commercial Distribution

  • 06945664821155 ()


  • Pulse oximeter probe, reusable
Reusable SpO2 Sensor/超思/Finger clip/Adult/3.0M/LP6
Unimed Medical Supplies, Inc.
U410B-96
In Commercial Distribution

  • 06945664821162 ()


  • Pulse oximeter probe, reusable
Sleep ASA - Preformed Tooth Positioner
ALLESEE AOA-PRO
3000-0131
In Commercial Distribution

  • 00889989075069 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
Reverse Lip ASA Tapered 32x175mm
THOMPSON SURGICAL INSTRUMENTS, INC.
6067
In Commercial Distribution

  • 00841536136166 ()


  • Surgical retraction system, reusable
Reverse Lip ASA Tapered 25x175mm
THOMPSON SURGICAL INSTRUMENTS, INC.
6066
In Commercial Distribution

  • 00841536136159 ()


  • Surgical retraction system, reusable
Reverse Lip ASA Rigid 32x175mm
THOMPSON SURGICAL INSTRUMENTS, INC.
6065
In Commercial Distribution

  • 00841536136142 ()


  • Surgical retraction system, reusable
Reverse Lip ASA Rigid 25x70mm
THOMPSON SURGICAL INSTRUMENTS, INC.
6062
In Commercial Distribution

  • 00841536136128 ()


  • Surgical retraction system, reusable
Reverse Lip ASA Rigid 32x120mm
THOMPSON SURGICAL INSTRUMENTS, INC.
5883
In Commercial Distribution

  • 00841536135381 ()


  • Surgical retraction system, reusable
Reverse Lip ASA Rigid 32x175mm
THOMPSON SURGICAL INSTRUMENTS, INC.
5804
In Commercial Distribution

  • 00841536135053 ()


  • Surgical retraction system, reusable
Reverse Lip ASA Malleable 25mm
THOMPSON SURGICAL INSTRUMENTS, INC.
5868
In Commercial Distribution

  • 00841536128376 ()


  • Surgical retraction system, reusable
Reverse Lip ASA Rigid 25x90mm
THOMPSON SURGICAL INSTRUMENTS, INC.
SL46259RET
In Commercial Distribution

  • 00841536126730 ()


  • Surgical retraction system, reusable
Reverse Lip ASA Rigid 25x80mm
THOMPSON SURGICAL INSTRUMENTS, INC.
SL46258RET
In Commercial Distribution

  • 00841536126723 ()


  • Surgical retraction system, reusable
Reverse Lip ASA Rigid 25x90mm
THOMPSON SURGICAL INSTRUMENTS, INC.
SL46259RE
In Commercial Distribution

  • 00841536126716 ()


  • Surgical retraction system, reusable
Reverse Lip ASA Rigid 25x80mm
THOMPSON SURGICAL INSTRUMENTS, INC.
SL46258RE
In Commercial Distribution

  • 00841536126709 ()


  • Surgical retraction system, reusable
Reverse Lip ASA Tapered 25x225mm
THOMPSON SURGICAL INSTRUMENTS, INC.
6595
In Commercial Distribution

  • 00841536139914 ()


  • Surgical retraction system, reusable
Reverse Lip ASA Malleable 25mm
THOMPSON SURGICAL INSTRUMENTS, INC.
6429
In Commercial Distribution

  • 00841536139273 ()


  • Surgical retraction system, reusable
Reverse Lip ASA Tapered 25x120mm
THOMPSON SURGICAL INSTRUMENTS, INC.
6417
In Commercial Distribution

  • 00841536139167 ()


  • Surgical retraction system, reusable
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