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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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Engage Android Rechargeable OTC Beige Replacement Left
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831788 ()
10080-L REPLACE

  • Air-conduction hearing aid, receiver-in-the-ear
Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,.
Persona Medical
Evok 1600 Wireless
In Commercial Distribution

  • 00851362008070 ()


  • Air-conduction hearing aid, behind-the-ear
Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with RxEars APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,.
Persona Medical
RxEars RX8
In Commercial Distribution

  • 00851362008056 ()


  • Air-conduction hearing aid, behind-the-ear
Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with RxEars APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,.
Persona Medical
RxEars RX7
In Commercial Distribution

  • 00851362008018 ()


  • Air-conduction hearing aid, behind-the-ear
SAM is a web application used to obtain, track and trend patient data pertaining to the management of anemia, and to provide a schedule of erythropoiesis-stimulating agent (ESA) dosage recommendations to help achieve and maintain target hemoglobin (Hgb) levels in hemodialysis patients. The device is intended to help clinicians manage chronic anemia.
Dosis Inc.
1
In Commercial Distribution

  • 00860005737512 ()


  • Nephrology information system application software
SURGICAL CHISELS 13K/TG 3.5 / 3 mm
Power Dental U.S.A. Inc.
2001
In Commercial Distribution

  • D94320010 ()
2001

  • Dressing/utility forceps, scissors-like, reusable
  • Periodontal hoe
#13/TG DE CURRETTE/CHISEL, #6 HANDLE
HU-FRIEDY MFG. CO., LLC
S13K/TG6
In Commercial Distribution

  • 10889950022556 ()
S13K/TG6

  • Periodontal file/rasp, manual
S13K/TG COMB. 6 MM #6 Handle
HU-FRIEDY MFG. CO., LLC
PJO/36
In Commercial Distribution

  • 10889950018955 ()
PJO/36

  • Periodontal file/rasp, manual
S13K/TG COMB. 5 MM #6 Handle
HU-FRIEDY MFG. CO., LLC
PJO/26
In Commercial Distribution

  • 10889950018924 ()
PJO/26

  • Periodontal file/rasp, manual
S13K/TG COMB. 4 MM #6 Handle
HU-FRIEDY MFG. CO., LLC
PJO/16
In Commercial Distribution

  • 10889950018900 ()
PJO/16

  • Periodontal file/rasp, manual
S13K/TG DE Curette/Chisel, Black Line
HU-FRIEDY MFG. CO., LLC
S13K/TGX
In Commercial Distribution

  • 10889950110321 ()
S13K/TGX

  • Periodontal file/rasp, manual
XiVE® TG Lab Set Bridge cast-to
Dentsply Implants Manufacturing GmbH
32259905
Not in Commercial Distribution

  • EFRI322599052 ()
25-9905

  • Dental implant suprastructure kit
XiVE® TG Lab Set Bridge castable
Dentsply Implants Manufacturing GmbH
32259900
Not in Commercial Distribution

  • EFRI322599002 ()
25-9900

  • Dental implant suprastructure kit
XiVE® TG Lab Set Castable Coping
Dentsply Implants Manufacturing GmbH
32259800
Not in Commercial Distribution

  • EFRI322598002 ()
25-9800

  • Dental implant suprastructure kit
XiVE® TG Lab Set Titanium Coping
Dentsply Implants Manufacturing GmbH
32259700
Not in Commercial Distribution

  • EFRI322597002 ()
25-9700

  • Dental implant suprastructure kit
XiVE® TG Abutment angled D3.4-4.5/A15
Dentsply Implants Manufacturing GmbH
32254510
Not in Commercial Distribution

  • EFRI322545102 ()
25-4510

  • Dental implant suprastructure, permanent, preformed
XiVE® TG Abutment straight D3.4-4.5/A0
Dentsply Implants Manufacturing GmbH
32254500
Not in Commercial Distribution

  • EFRI322545002 ()
25-4500

  • Dental implant suprastructure, permanent, preformed
XiVE® TG Cast-to Waxing Sleeve D3.4-4.5
Dentsply Implants Manufacturing GmbH
32254246
Not in Commercial Distribution

  • EFRI322542462 ()
25-4246

  • Dental implant suprastructure, permanent, preformed
XiVE® TG plus Implant D4.5/L15
Dentsply Implants Manufacturing GmbH
32252455
Not in Commercial Distribution

  • EFRI322524552 ()
25-2455

  • Screw endosteal dental implant, one-piece
XiVE® TG plus Implant D4.5/L13
Dentsply Implants Manufacturing GmbH
32252453
Not in Commercial Distribution

  • EFRI322524532 ()
25-2453

  • Screw endosteal dental implant, one-piece
XiVE® TG plus Implant D4.5/L11
Dentsply Implants Manufacturing GmbH
32252452
Not in Commercial Distribution

  • EFRI322524522 ()
25-2452

  • Screw endosteal dental implant, one-piece
XiVE® TG plus Implant D4.5/L9.5
Dentsply Implants Manufacturing GmbH
32252451
Not in Commercial Distribution

  • EFRI322524512 ()
25-2451

  • Screw endosteal dental implant, one-piece
XiVE® TG plus Implant D4.5/L8
Dentsply Implants Manufacturing GmbH
32252450
Not in Commercial Distribution

  • EFRI322524502 ()
25-2450

  • Screw endosteal dental implant, one-piece
XiVE® TG plus Implant D3.8/L15
Dentsply Implants Manufacturing GmbH
32252445
Not in Commercial Distribution

  • EFRI322524452 ()
25-2445

  • Screw endosteal dental implant, one-piece
XiVE® TG plus Implant D3.8/L13
Dentsply Implants Manufacturing GmbH
32252443
Not in Commercial Distribution

  • EFRI322524432 ()
25-2443

  • Screw endosteal dental implant, one-piece
XiVE® TG plus Implant D3.8/L11
Dentsply Implants Manufacturing GmbH
32252442
Not in Commercial Distribution

  • EFRI322524422 ()
25-2442

  • Screw endosteal dental implant, one-piece
XiVE® TG plus Implant D3.8/L9.5
Dentsply Implants Manufacturing GmbH
32252441
Not in Commercial Distribution

  • EFRI322524412 ()
25-2441

  • Screw endosteal dental implant, one-piece
XiVE® TG plus Implant D3.8/L8
Dentsply Implants Manufacturing GmbH
32252440
Not in Commercial Distribution

  • EFRI322524402 ()
25-2440

  • Screw endosteal dental implant, one-piece
XiVE® TG plus Implant D3.4/L15
Dentsply Implants Manufacturing GmbH
32252435
Not in Commercial Distribution

  • EFRI322524352 ()
25-2435

  • Screw endosteal dental implant, one-piece
XiVE® TG plus Implant D3.4/L13
Dentsply Implants Manufacturing GmbH
32252433
Not in Commercial Distribution

  • EFRI322524332 ()
25-2433

  • Screw endosteal dental implant, one-piece
XiVE® TG plus Implant D3.4/L11
Dentsply Implants Manufacturing GmbH
32252432
Not in Commercial Distribution

  • EFRI322524322 ()
25-2432

  • Screw endosteal dental implant, one-piece
XiVE® TG plus Implant D3.4/L9.5
Dentsply Implants Manufacturing GmbH
32252431
Not in Commercial Distribution

  • EFRI322524312 ()
25-2431

  • Screw endosteal dental implant, one-piece
XiVE® TG Cover Screw for Implants
Dentsply Implants Manufacturing GmbH
32251400
Not in Commercial Distribution

  • EFRI322514002 ()
25-1400

  • Dental implant suprastructure, temporary, preformed, single-use
TG Ab Dil.Ancill.RP (2PK) - CENTAUR - CONS - 2x5mL
Siemens Healthcare Diagnostics Inc.
10310430
In Commercial Distribution

  • 00630414460833 ()
  • 00630414003368 ()
128280

  • Buffered sample diluent IVD
TG Ab Sample Diluent - IMMULITE - CAL - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387073
In Commercial Distribution

  • 00630414954318 ()
L2TYZ

  • Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, control
TG PRO TACO ANKLE 30% XL LEFT
MEDI MANUFACTURING, INC.
501996
In Commercial Distribution

  • 00636257157121 ()


  • Ankle/foot orthosis
TG PRO TACO ANKLE 30% LG LEFT
MEDI MANUFACTURING, INC.
501995
In Commercial Distribution

  • 00636257157114 ()


  • Ankle/foot orthosis
TG PRO TACO ANKLE 30% MD LEFT
MEDI MANUFACTURING, INC.
501994
In Commercial Distribution

  • 00636257157107 ()


  • Ankle/foot orthosis
TG PRO TACO ANKLE 30% SM LEFT
MEDI MANUFACTURING, INC.
501993
In Commercial Distribution

  • 00636257157091 ()


  • Ankle/foot orthosis
TG PRO TACO ANKLE 30% XS LEFT
MEDI MANUFACTURING, INC.
501992
In Commercial Distribution

  • 00636257157084 ()


  • Ankle/foot orthosis
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