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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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HOW PLIERS STRAIGHT
AMERICAN EAGLE INSTRUMENTS, INC.
AE201-106
Not in Commercial Distribution

  • 00841013101755 ()
AE201-106

  • Orthodontic pliers
Superb How Curved
ORTHOSOURCE
871-103
In Commercial Distribution

  • D9118711030 ()


  • Orthodontic pliers
Superb How Large
ORTHOSOURCE
871-102
In Commercial Distribution

  • D9118711020 ()


  • Orthodontic pliers
Superb How Small
ORTHOSOURCE
871-101
In Commercial Distribution

  • D9118711010 ()


  • Orthodontic pliers
How Plier (straight)
ORTHOPLI CORP.
O11
In Commercial Distribution

  • D917O110 ()


  • Orthodontic pliers
How Pliers, Offset
HU-FRIEDY MFG. CO., LLC
678-204
In Commercial Distribution

  • 10889950003340 ()
678-204

  • Orthodontic pliers
How Pliers, Straight
HU-FRIEDY MFG. CO., LLC
678-203
In Commercial Distribution

  • 10889950003333 ()
678-203

  • Orthodontic pliers
HOW pliers cvd.carb.coat
A. Schweickhardt GmbH & Co. KG
5324-F
In Commercial Distribution

  • E8965324F0 ()
5324-F

  • Wire holding/twisting pliers
PLIER HOW STRAIGHT
DARBY DENTAL SUPPLY, LLC
5257309
In Commercial Distribution

  • 00889813066607 ()


  • Surgical flat-nosed pliers
PLIER HOW CURVED
DARBY DENTAL SUPPLY, LLC
5257308
In Commercial Distribution

  • 00889813066591 ()


  • Orthopaedic cerclage applier
Curved How pliers
Schobell Industrial Ltda
QO.111.00
In Commercial Distribution

  • 07898506813957 ()
QO.111.00

  • Orthodontic pliers
Straight How pliers
Schobell Industrial Ltda
QO.110.00
In Commercial Distribution

  • 07898506813940 ()
QO.110.00

  • Orthodontic pliers
How Plier, Curved
POMEE CORPORATION
7153
In Commercial Distribution

  • G15771530 ()
7153

  • Orthodontic pliers
OFFSET HOW PLIERS
ORMCO CORPORATION
866-2017
In Commercial Distribution

  • 00889989082364 ()


  • Orthodontic pliers
STRAIGHT HOW PLIERS
ORMCO CORPORATION
866-2016
In Commercial Distribution

  • 00889989082357 ()


  • Orthodontic pliers
HOW PLIERS CURVED
LEONE SPA
P1909-00
In Commercial Distribution

  • 08033707069478 ()
P1909-00

  • Orthodontic pliers
HOW PLIERS STRAIGHT
LEONE SPA
P1908-00
In Commercial Distribution

  • 08033707069461 ()
P1908-00

  • Orthodontic pliers
HOW PLIERS STRAIGHT
LEONE SPA
P1907-00
In Commercial Distribution

  • 08033707069454 ()
P1907-00

  • Orthodontic pliers
HOW PLIER CURVED
Rmo, Inc.
I00111
In Commercial Distribution

  • 00885797097163 ()


  • Orthodontic pliers
HOW PLIER STRAIGHT
Rmo, Inc.
I00110
In Commercial Distribution

  • 00885797097156 ()


  • Orthodontic pliers
The NightWare device includes a software application and the NightWare server. The device uses an Apple Watch® and an Apple iPhone® for its platform. These components monitor your sleep behavior and, using a proprietary formula, creates a unique sleep profile to help you get a better night’s sleep. NightWare is designed to monitor your heart rate and movement throughout the night and occasionally provide vibrotactile interventions (haptic feedback) through the Apple Watch while you are sleeping. These interventions will occur when NightWare detects that you have exceeded a certain threshold and will disrupt the phenomena consistent with a nightmare at the time that it is occurring. The first night you use NightWare, the watch will not provide any of these interventions because it is gathering enough data to create your unique sleep profile. The data that NightWare collects from the Apple Watch includes: Heart Rate, Body Movement (Acceleration),Body Position (Rotation). This information is securely sent to the NightWare servers and processed to help you improve the quality of your sleep.
Nightware Incorporated
100001
In Commercial Distribution

  • 00860005400706 ()


  • Sleep disorder interpretive software, patient-use
Also covers the following minor/medium updates: v3.1.0: (01)00860001471731(11)210526(10)310; v3.1.1 (01)00860001471731(11)210604(10)311; v3.1.2 (01)00860001471731(11)210625(10)312; v3.2.0 (01)00860001471731(11)210713(10)320; v3.2.1. (01)00860001471731(11)210804(10)321; v3.2.2 (01)00860001471731(11)210917(10)322; v3.2.3 (01)00860001471731(11)211026(10)323 ;v3.2.4 (01)00860001471731(11)211123(10)324; v3.4.0: (01)00860001471731(11)220609(10)340; v3.5.1 (01)00860001471731(11)220718(10)351; v3.6.0 (01)00860001471731(11)220926(10)360; v3.6.2(01)00860001471731(11)221024(10)362; v3.7.0(01)00860001471731(11)221116(10)370; v3.8.0(01)00860001471731(11)221215(10)380; v3.8.1(01)00860001471731(11)230127(10)381; v3.9.0(01)00860001471731(11)230217(10)390; v3.9.1(01)00860001471731(11)230417(10)391; v3.9.2 (01)00860001471731(11)230609(10)392; v3.9.3 (01)00860001471731(11)230714(10)393; v3.10.0 (01)00860001471731(11)231013(10)3100
AMPLIFON SPA
Android v3
In Commercial Distribution

  • 00860001471731 ()


  • Hearing aid/implant system remote control
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
How Utility Pliers, Straight
Surgical Direct, Inc.
SD90297203
In Commercial Distribution

  • B382SD902972030 ()
SD90297203

  • Dressing/utility forceps, scissors-like, reusable
Plier How 111 Curved
HENRY SCHEIN, INC.
1127204
In Commercial Distribution

  • 00304040049327 ()
1127204

  • Orthodontic pliers
Plier How 110 Straight
HENRY SCHEIN, INC.
1127203
In Commercial Distribution

  • 00304040049310 ()
1127203

  • Orthodontic pliers
How Crown Pliers Straight
ELMED INCORPORATED
01-7420
In Commercial Distribution

  • 00842180184114 ()
01-7420

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Standard How Utility Plier
ORTHO TECHNOLOGY, INC.
400-115
Not in Commercial Distribution

  • 00190730083753 ()


  • Orthodontic pliers
Triumph® How Pliers
ORTHO ORGANIZERS, INC.
205-203
In Commercial Distribution

  • 00190707081638 ()


  • Orthodontic pliers
ORTHODONTIC PLIER HOW THIN
Power Dental U.S.A. Inc.
5622
In Commercial Distribution

  • D9435622 ()
5622

  • Orthodontic pliers
ORTHODONTIC PLIER HOW STR
Power Dental U.S.A. Inc.
5612
In Commercial Distribution

  • D9435612 ()
5612

  • Orthodontic pliers
Superb How Band Seating
ORTHOSOURCE
871-104
In Commercial Distribution

  • D9118711040 ()


  • Orthodontic pliers
How pliers, straight, EQ-Line
DENTAURUM GmbH & Co.KG
045-006-00
In Commercial Distribution

  • J011045006000 ()


  • Orthodontic pliers
How pliers, straight, Premium-Line
DENTAURUM GmbH & Co.KG
003-112-00
In Commercial Distribution

  • J011003112000 ()


  • Orthodontic pliers
How pliers, curved, Premium-Line
DENTAURUM GmbH & Co.KG
003-111-00
In Commercial Distribution

  • J011003111000 ()


  • Orthodontic pliers
Lap Joint How Plier
ORTHOPLI CORP.
OL-11
In Commercial Distribution

  • D917OL110 ()


  • Orthodontic pliers
How pliers straight, modified
A. Schweickhardt GmbH & Co. KG
5321
In Commercial Distribution

  • E89653210 ()
5321

  • Wire holding/twisting pliers
How Utility Plier Straight
Young Innovations, Inc.
G009
In Commercial Distribution

  • 10840326408558 ()
  • 00840326408551 ()
G009

  • Orthodontic pliers
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