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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Integra® Jarit® Hartmann Tuning Fork, 512C, Aluminum Alloy
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
380167
In Commercial Distribution

  • M2743801671 ()
  • 10381780462415 ()
380-167

  • Tuning fork
Integra® Jarit® Hartmann Tuning Fork, 256C, Aluminum Alloy
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
380166
In Commercial Distribution

  • M2743801661 ()
  • 10381780462408 ()
380-166

  • Tuning fork
Integra® Jarit® Hartmann Tuning Fork, 128C, Aluminum Alloy
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
380165
In Commercial Distribution

  • M2743801651 ()
  • 10381780462392 ()
380-165

  • Tuning fork
Tuning Forks, Set of 5 Includes: C-128, C-256, C-512, C-1024 and C-2048, Vinyl Zippered Case
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
19-120
Not in Commercial Distribution

  • H834191201 ()
  • 10381780463863 ()
19-120

  • Tuning fork
Integra® Miltex® Student Grade Tuning Fork, C-512 Vibrations
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
19-117
In Commercial Distribution

  • H834191170 ()
  • 10381780463856 ()
19-117

  • Tuning fork
Integra® Miltex® Student Grade Tuning Fork, C-256 Vibrations
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
19-115
In Commercial Distribution

  • H834191150 ()
  • 10381780463849 ()
19-115

  • Tuning fork
Integra® Miltex® Student Grade Tuning Fork, C-128 Vibrations
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
19-113
In Commercial Distribution

  • H834191130 ()
  • 10381780463832 ()
19-113

  • Tuning fork
Integra® Miltex® Tuning Fork, Aluminum Alloy, C-4096 Vibrations
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
19-112
In Commercial Distribution

  • H834191120 ()
  • 10381780463825 ()
19-112

  • Tuning fork
Integra® Miltex® Tuning Fork, Aluminum Alloy, C-2048 Vibrations
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
19-110
In Commercial Distribution

  • H834191100 ()
  • 10381780463818 ()
19-110

  • Tuning fork
Integra® Miltex® Tuning Fork, Aluminum Alloy, C-1024 Vibrations
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
19-108
In Commercial Distribution

  • H834191080 ()
  • 10381780463801 ()
19-108

  • Tuning fork
Integra® Miltex® Tuning Fork, Aluminum Alloy, C-512 Vibrations
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
19-106
In Commercial Distribution

  • H834191060 ()
  • 10381780463795 ()
19-106

  • Tuning fork
Integra® Miltex® Tuning Fork, Aluminum Alloy, C-256 Vibrations
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
19-104
In Commercial Distribution

  • H834191040 ()
  • 10381780463788 ()
19-104

  • Tuning fork
Integra® Miltex® Tuning Fork, Aluminum Alloy, C-128 Vibrations
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
19-102
In Commercial Distribution

  • H834191020 ()
  • 10381780463771 ()
19-102

  • Tuning fork
Integra® Miltex® Tuning Fork, Aluminum Alloy, C-64 Vibrations
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
19-100
In Commercial Distribution

  • H834191000 ()
  • 10381780463764 ()
19-100

  • Tuning fork
Integra® Tuning Fork, C2048, without Weights
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3724235
In Commercial Distribution

  • 10381780084273 ()
3724235

  • Tuning fork
Integra® Tuning Fork, C1024, without Weights
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3724234
In Commercial Distribution

  • 10381780084266 ()
3724234

  • Tuning fork
Integra® Tuning Fork, C512, without Weights
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3724233
In Commercial Distribution

  • 10381780084259 ()
3724233

  • Tuning fork
Integra® Tuning Fork, C256, with Weights
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3724232
In Commercial Distribution

  • 10381780084242 ()
3724232

  • Tuning fork
Integra® Tuning Fork, C128, with Weights
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3724231
In Commercial Distribution

  • 10381780084235 ()
3724231

  • Tuning fork
1024Hz Frequency Tuning Fork
RASHMAN CORPORATION
C-1024
In Commercial Distribution

  • 00786511010249 ()


  • Tuning fork
512Hz Frequency Tuning Fork
RASHMAN CORPORATION
C-512
In Commercial Distribution

  • 00786511005122 ()


  • Tuning fork
128Hz Frequency Tuning Fork with Weights
RASHMAN CORPORATION
C-128
In Commercial Distribution

  • 00786511001285 ()


  • Tuning fork
256Hz Frequency Tuning Fork with Weights
RASHMAN CORPORATION
C-256
In Commercial Distribution

  • 00786511002565 ()


  • Tuning fork
Symmetry® Tuning Fork, C-2048 w/o Weights, Aluminum Alloy
SYMMETRY SURGICAL INC.
62-0714
In Commercial Distribution

  • 00887482116630 ()
62-0714

  • Tuning fork
Symmetry® Tuning Fork, C-1024 w/o Weights, Aluminum Alloy
SYMMETRY SURGICAL INC.
62-0713
In Commercial Distribution

  • 00887482116623 ()


  • Tuning fork
Symmetry® Tuning Fork, C-512 w/o Weights, Aluminum Alloy
SYMMETRY SURGICAL INC.
62-0712
In Commercial Distribution

  • 00887482116616 ()
62-0712

  • Tuning fork
Symmetry® Tuning Fork, C-256 w/Weights, Aluminum Alloy
SYMMETRY SURGICAL INC.
62-0711
In Commercial Distribution

  • 00887482116609 ()
62-0711

  • Tuning fork
Symmetry® Tuning Fork, C-128 w/Weights, Aluminum Alloy
SYMMETRY SURGICAL INC.
62-0710
In Commercial Distribution

  • 00887482116593 ()
62-0710

  • Tuning fork
TUNING FRK HARTMAN C-512 N175C
Bausch & Lomb Incorporated
N0177 C
In Commercial Distribution

  • 00757770411702 ()
N0177 C

  • Tuning fork
INMOVILIZADOR DE DEDO PULGAR- U U
PANTYMED S.A.
1102-6020 U U
In Commercial Distribution

  • 07798094547930 ()


  • Wrist immobilizer, reusable
U OF U LVAD DRESSING SYSTEM
CENTURION MEDICAL PRODUCTS CORPORATION
DM535
In Commercial Distribution

  • 00653160286434 ()
  • 10653160286431 ()
DM535

  • General surgical procedure kit, medicated
Rabbit Polyclonal Anti-Human Amyloid Precursor Protein (APP)
RICHARD-ALLAN SCIENTIFIC COMPANY
RB-9023-R7
In Commercial Distribution

  • 00673693398602 ()

  • Total Volume: 7 Milliliter


  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Rabbit Polyclonal Anti-Human Amyloid Precursor Protein (APP)
RICHARD-ALLAN SCIENTIFIC COMPANY
RB-9023-P1
In Commercial Distribution

  • 00673693398572 ()

  • Total Volume: 0.5 Milliliter


  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Rabbit Polyclonal Anti-Human Amyloid Precursor Protein (APP)
RICHARD-ALLAN SCIENTIFIC COMPANY
RB-9023-P0
In Commercial Distribution

  • 00673693398565 ()

  • Total Volume: 0.1 Milliliter


  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Rabbit Polyclonal Anti-Human Amyloid Precursor Protein (APP)
RICHARD-ALLAN SCIENTIFIC COMPANY
RB-9023-P
In Commercial Distribution

  • 00673693398558 ()

  • Total Volume: 1 Milliliter


  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
OB V2 RING KIT TI LG-No App
OSSUR AMERICAS, INC.
515500V2
Not in Commercial Distribution

  • 05690977308695 ()
515500V2

  • Cervical spine immobilization head ring
OB V2 RING KIT TI STD-No App
OSSUR AMERICAS, INC.
515400V2
Not in Commercial Distribution

  • 05690977308688 ()
515400V2

  • Cervical spine immobilization head ring
OB V2 RING KIT TI SM-No App
OSSUR AMERICAS, INC.
515300V2
Not in Commercial Distribution

  • 05690977308671 ()
515300V2

  • Cervical spine immobilization head ring
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
FLEXICARE MEDICAL LIMITED
038-94-620U
In Commercial Distribution

  • 05055788777694 ()


  • Laryngeal mask airway, single-use
SOFTWARE 9734472 SONONAV CAL APP FOR SC
MEDTRONIC NAVIGATION, INC.
9734472
In Commercial Distribution

  • 00643169183407 ()


  • Multi-purpose stereotactic surgery system
DreamMapper App iOS, Asia-Pacific Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054288 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper App iOS, EMEA Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054271 ()
1128264

  • Self-care monitoring/reporting software
G5 Mobile Android App Stand Alone Software
Dexcom, Inc.
SW10940
In Commercial Distribution

  • 00386270000293 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
G5 Mobile IOS App Stand Alone Software
Dexcom, Inc.
SW10611
In Commercial Distribution

  • 00386270000002 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
App Control for ACRL-9100 Device v.1
COMPASS HEALTH BRANDS CORP.
ACRL-9100APP
In Commercial Distribution



  • Physical therapy transcutaneous neuromuscular electrical stimulation system
App Control for ACRL-9100 Device v.0
COMPASS HEALTH BRANDS CORP.
ACRL-9100APP
Not in Commercial Distribution

  • 00023601091000 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
APP System, Standard, 220 Volt, 1/ea
Drive Devilbiss Healthcare
14002E-220
Not in Commercial Distribution

  • 10822383227785 ()
  • 00822383227788 ()


  • Alternating-pressure bed mattress overlay system
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay, reusable
Symphony True LAL & APP Matt Repl Sys
Drive Devilbiss Healthcare
14500
Not in Commercial Distribution

  • 00822383580913 ()


  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure bed mattress overlay system
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
MAR COR PURIFICATION, INC.
102M16B2E
In Commercial Distribution

  • 00817492021969 ()

  • Width: 38 Inch
  • Depth: 29 Inch
  • Height: 80.5 Inch
  • Weight: 783 Pound


  • Reverse-osmosis water purification system
APP PAD W/O HEAD & FOOT FLAPS
COMPASS HEALTH BRANDS CORP.
1002
In Commercial Distribution

  • 30815067040170 ()
  • 00815067040179 ()


  • Alternating-pressure bed mattress overlay, reusable
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