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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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ParaPost Fiber Lux - D661PF17151

5 ParaPost FiberLux Posts, Size 5
COLTENE/WHALEDENT INC
PF1715
In Commercial Distribution

  • D661PF17151 ()
  • D661PF17150 ()
  • 00840016201707 ()


  • Root canal post, preformed

gSource - 00840314210135

Bunge Evisceration Spoon 5", #5, 12.0mm
GSOURCE LLC
gS 27.7712
In Commercial Distribution

  • 00840314210135 ()
gS 27.7712

  • Lens spoon

Halyard - 10680651134803

SURGPN,400X5+5,CBI,-,OQ,5
Avanos Medical, Inc.
13480
In Commercial Distribution

  • 30680651134807 ()
  • 10680651134803 ()
CBI003

  • Elastomeric infusion pump system

Halyard - 10680651136876

SURGPN,400X5+5,PMPSAF,-,OQ,5
Avanos Medical, Inc.
13687
In Commercial Distribution

  • 30680651136870 ()
  • 10680651136876 ()
P400X5 plus5-60

  • Elastomeric infusion pump system

Halyard - 10680651136869

SURGPN,400X2-14+5,PMPSAF,-,OQ,5
Avanos Medical, Inc.
13686
In Commercial Distribution

  • 30680651136863 ()
  • 10680651136869 ()
P400X2-14 plus5

  • Elastomeric infusion pump system

Halyard - 10680651136845

SURGPN,400X1-7+5,PMPSAF,-,OQ,5
Avanos Medical, Inc.
13684
In Commercial Distribution

  • 30680651136849 ()
  • 10680651136845 ()
P400X1-7 plus5-

  • Elastomeric infusion pump system

Supremo Instrumentos - 07908854000340

Tunelizador 5 (DLC) - Tunneler 5 DLC
ANDRE GREGATE BRAGA INSTRUMENTOS LTDA
S2937B
In Commercial Distribution

  • 07908854000340 ()
S2937B

  • Periosteal elevator, reusable

Phospholin ES w/Calcium - 10859394006238

APTT reagent 5 x 5 ml
R 2 DIAGNOSTICS, INC.
21-405
In Commercial Distribution

  • 10859394006238 ()
  • 00859394006231 ()
21-405

  • Activated partial thromboplastin time (APTT) IVD, reagent

MatriStem - 00386190000403

Surgical Matrix 5 x 5 cm
ACELL, INC.
PSMX0505
Not in Commercial Distribution

  • 00386190000403 ()

  • Rectangle device approximately 5 x 5 cm
PSMX0505

  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial

Cytal® - 00386190001011

Burn Matrix 5 X 5 cm
ACELL, INC.
BMM0505
Not in Commercial Distribution

  • 00386190001011 ()

  • Rectangle device approximately 5 x 5 cm
BMM0505

  • Animal-derived wound matrix dressing

ELEVATOR - 00888118059598

SEPTUM, COTTLE, 5/5 MM TIP
KLS-Martin L.P.
37-559-23-07
In Commercial Distribution

  • 00888118059598 ()

  • 23 CM


  • ENT elevator

APTUS - 07630037848844

5/5 Case Effective Height 144mm
Medartis AG
A-6505
In Commercial Distribution

  • 07630037848844 ()
A-6505

  • Device sterilization/disinfection container, reusable

APTUS - 07630037848912

5/5 Case Effective Height 96mm
Medartis AG
A-6517
In Commercial Distribution

  • 07630037848912 ()
A-6517

  • Device sterilization/disinfection container, reusable

APTUS - 07630037848868

5/5 Case Effective Height 48mm
Medartis AG
A-6507
In Commercial Distribution

  • 07630037848868 ()
A-6507

  • Device sterilization/disinfection container, reusable

BOSS Instruments - 00888515154773

Hoke Osteotome, cvd, 5", 5/16"
BOSS INSTRUMENTS, LTD., INC.
70-3753
In Commercial Distribution

  • 00888515154773 ()
70-3753

  • Orthopaedic osteotome

BOSS Instruments - 00888515154698

Hoke Osteotome, str, 5", 5/8"
BOSS INSTRUMENTS, LTD., INC.
70-3736
In Commercial Distribution

  • 00888515154698 ()
70-3736

  • Orthopaedic osteotome

BOSS Instruments - 00888515154636

Hoke Osteotome, str, 5", 5/16"
BOSS INSTRUMENTS, LTD., INC.
70-3733
In Commercial Distribution

  • 00888515154636 ()
70-3733

  • Orthopaedic osteotome

BOSS Instruments - 00888515154834

Hoke Osteotome, cvd, 5", 5/8"
BOSS INSTRUMENTS, LTD., INC.
70-3756
In Commercial Distribution

  • 00888515154834 ()
70-3756

  • Orthopaedic osteotome

Surgical Direct - B382SD923867160

5 5/8 inch Spatula Packer
Surgical Direct, Inc.
SD92386716
In Commercial Distribution

  • B382SD923867160 ()
SD92386716

  • Bone lever/elevator, reusable

Surgical Direct - B382SD920686200

5 5/8" Drum Elevator, 2.0mm
Surgical Direct, Inc.
SD92068620
In Commercial Distribution

  • B382SD920686200 ()
SD92068620

  • Periosteal elevator, reusable

APTUS - 07630894803543

5/5 Case Effective Height 96mm
Medartis AG
A-6517
In Commercial Distribution

A-6517

  • Device sterilization/disinfection container, reusable

APTUS - 07630894803444

5/5 Case Effective Height 48mm
Medartis AG
A-6507
In Commercial Distribution

A-6507

  • Device sterilization/disinfection container, reusable

APTUS - 07630894803413

5/5 Case Effective Height 144mm
Medartis AG
A-6505
In Commercial Distribution

A-6505

  • Device sterilization/disinfection container, reusable

NA - 00810050245425

WEDGE, 5" x 5" x 15"
DOMICO MED-DEVICE, LLC
108-8
Not in Commercial Distribution

  • 00810050245425 ()

  • Height: 5 Inch
  • Width: 5 Inch
  • Length: 15 Inch


  • Multifunction body cushion
  • Radiological general body-part positioner

NA - 00810050244794

WEDGE, 5" x 5" x 15"
DOMICO MED-DEVICE, LLC
108
In Commercial Distribution

  • 00810050244794 ()

  • Height: 5 Inch
  • Width: 5 Inch
  • Length: 15 Inch


  • Multifunction body cushion
  • Radiological general body-part positioner

Pryor - 00761887000957

5 leg knockdown,5 hook, SW
PRYOR PRODUCTS
136T
In Commercial Distribution

  • 00761887000957 ()
136T

  • Freestanding/bed-attached intravenous pole

Synchron - 15099590221256

CAL 5 PLUS Calibrator 5 Plus
Beckman Coulter, Inc.
469975
In Commercial Distribution

  • 15099590221256 ()
469975

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

1ml Luer Lock LDS Syringe - 03760173232697

Sterile hypodermic syringe for single use
AESTHETIC GROUP
L10100
In Commercial Distribution

  • 03760173232697 ()
  • 03760173233342 ()
  • 03760173233366 ()
L10100

  • General-purpose syringe, single-use

1ml Luer Slip LDS Syringe - 03760173232680

Sterile hypodermic syringe for single use
AESTHETIC GROUP
S10100
In Commercial Distribution

  • 03760173233335 ()
  • 03760173232680 ()
  • 03760173233359 ()
S10100

  • General-purpose syringe, single-use

MEDICOM - 10686864869822

SAFEGAUZE HEMOSTAT STERILE 4PLY WHITE
AMD Medicom Inc
4900
Not in Commercial Distribution

  • 20686864869829 ()
  • 10686864869822 ()
  • 00686864869825 ()

  • 0.75 x 0.75 Inch
4900

  • Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial

Medicom - 10686864060779

Medicom HemoStat - Topical Sterile Dressing - 4 Ply - White 0.75" x 0.75"
AMD Medicom Inc
4900-STAT
In Commercial Distribution

  • 20686864060776 ()
  • 10686864060779 ()
  • 00686864060772 ()

  • 0.75 x 0.75 Inch
4900-STAT

  • Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial

Medicom SafeGauze - 10686864055089

Medicom SafeGauze HemoStat - Topical Dental Dressing - Sterile - 4 Ply - White 0.75" x 0.75"
AMD Medicom Inc
4900-STAT
In Commercial Distribution

  • 20686864055086 ()
  • 10686864055089 ()
  • 00686864055082 ()

  • 0.75 x 0.75 Inch
4900-STAT

  • Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial

VITROS - 10758750035069

VITROS Immunodiagnostic Products Syphilis Calibrator
ORTHO CLINICAL DIAGNOSTICS
6177334
In Commercial Distribution

  • 20758750035066 ()
  • 10758750035069 ()
6177334

  • Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay

MEDICOM SAFEGAUZE HEMOSTAT - 20686864060219

Medicom SafeGauze HemoStat - Topical Dental Dressing - Sterile - 4 Ply - White 0.75" x 0.75" - sample
AMD Medicom Inc
4900-SP2
In Commercial Distribution

  • 00686864060215 ()
  • 20686864060219 ()

  • 0.75 x 0.75 Inch
4900-SP2

  • Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial

VISION 5/13 L-WRENCH - 00880304491946

No Description
Biomet Orthopedics, LLC
14270
In Commercial Distribution

  • 00880304491946 ()
14270

  • Surgical torque wrench, reusable

EPIQ 5 Ultrasound System - 00884838107502

No Description
Philips Ultrasound LLC
795204
In Commercial Distribution

  • 00884838107502 ()


  • General-purpose ultrasound imaging system

STA® - Fibrinogen 5 - 13607450006749

No Description
DIAGNOSTICA STAGO
00674
In Commercial Distribution

  • 13607450006749 ()
  • 03607450006742 ()


  • Fibrinogen assay (factor I) IVD, kit, clotting

DISCOVERY ELBOW 5 STEP - 00880304370333

No Description
Biomet Orthopedics, LLC
414912
In Commercial Distribution

  • 00880304370333 ()
414912

  • Bone-resection orthopaedic reamer, reusable

MOSAIC INSTRUMENT CASE #5 - 00880304397149

No Description
Biomet Orthopedics, LLC
595151
In Commercial Distribution

  • 00880304397149 ()
595151

  • Instrument tray, reusable

Anaesthetic Mask, Size 5# - 06923310903530

No Description
Hangzhou Formed Medical Devices Co.Ltd.
PA150205
In Commercial Distribution

  • 06923310903530 ()
PA150205

  • Anaesthesia face mask, single-use
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