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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NASOPHARYNGEAL AIRWAY 26 FR
KENTRON HEALTHCARE, INC.
826426
In Commercial Distribution

  • 00810003754516 ()
  • 00810003754509 ()
  • 00810003754523 ()


  • Nasopharyngeal airway, single-use
FITCH OBTURATOR 26 FRENCH
TELEFLEX INCORPORATED
IPN005339
In Commercial Distribution

  • 24026704517019 ()
  • 04026704517015 ()

  • Length: 17.875 Inch
351316

  • Centrally-inserted central venous catheter
FLAT PANEL LCD 26
Smith & Nephew, Inc.
72202591
In Commercial Distribution

  • 00885556541098 ()
72202591

  • Image display unit, colour
MOLAR BAND MAN 26
Rmo, Inc.
B00650
In Commercial Distribution

  • 00000008857972 ()
  • 00885797092366 ()


  • Orthodontic metal band
MOLAR BAND MAX 26
Rmo, Inc.
B00618
In Commercial Distribution

  • 00000008857972 ()
  • 00885797092045 ()


  • Orthodontic metal band
Nonsterile Equipment Large Cover for the Movement Footswitch 26” x 26”
DORNIER MEDTECH AMERICA, INC.
Equipment Cover (Movement Footswitch)
In Commercial Distribution

  • 10810116023025 ()
  • 00810116023028 ()
FTSXCVRLG

  • Medical equipment/instrument drape, single-use
No Description
Biomet Orthopedics, LLC
11-302135
In Commercial Distribution

  • 00880304494008 ()

  • 35 MM
11-302135

  • Uncoated hip femur prosthesis, modular
No Description
Biomet Orthopedics, LLC
904724
In Commercial Distribution

  • 00880304453302 ()

  • 35 MM
904724

  • Tendon/ligament bone anchor, non-bioabsorbable
Torque Limiting Handle, 35 in-lb
Seaspine Orthopedics Corporation
95-0127
In Commercial Distribution

  • 10889981094409 ()

  • 35 in-lb
95-0127

  • Surgical instrument handle, non-torque-limiting
No Description
Biomet Orthopedics, LLC
180031
In Commercial Distribution

  • 00880304268791 ()

  • 35 CM
180031

  • Knee femur stem prosthesis
HercepTest
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
K5204
Not in Commercial Distribution

  • 05700572031987 ()

  • 35 Tests


  • Human epidermal growth factor receptor 2 (HER2) protein IVD, kit, enzyme immunohistochemistry
c-Kit pharmDx for Autostainer
AGILENT TECHNOLOGIES, INC.
K1907
Not in Commercial Distribution

  • 05700571104057 ()

  • 35 Tests


  • CD117 (c-kit) cell marker IVD, kit, enzyme immunohistochemistry
EGFR pharmDx
AGILENT TECHNOLOGIES, INC.
K1492
Not in Commercial Distribution

  • 05700571103968 ()

  • 35 Tests


  • Epidermal growth factor receptor (EGFR) IVD, kit, enzyme immunohistochemistry
No Description
Biomet Orthopedics, LLC
101452
In Commercial Distribution

  • 00880304184596 ()

  • 35 MM
101452

  • Polyethylene patella prosthesis
XO drill for glenoid central screw
implantcast GmbH
78010176
In Commercial Distribution

  • 04048844620219 ()

  • 35 mm


  • Fluted surgical drill bit, reusable
3D/3D+ Punch Liner, Size 3-5, 18mm
Exactech, Inc.
03-CNB-PL-3518
In Commercial Distribution

  • 10885862628565 ()

  • Height: 18 Millimeter
  • Size 3-5
03-CNB-PL-3518

  • Surgical tamp, reusable
3D/3D+ Punch Liner, Size 3-5, 16mm
Exactech, Inc.
03-CNB-PL-3516
In Commercial Distribution

  • 10885862628558 ()

  • Height: 16 Millimeter
  • Size 3-5
03-CNB-PL-3516

  • Surgical tamp, reusable
3D/3D+ Punch Liner, Size 3-5, 14mm
Exactech, Inc.
03-CNB-PL-3514
In Commercial Distribution

  • 10885862628541 ()

  • Size 3-5
  • Height: 14 Millimeter
03-CNB-PL-3514

  • Surgical tamp, reusable
3D/3D+ Punch Liner, Size 3-5, 12mm
Exactech, Inc.
03-CNB-PL-3512
In Commercial Distribution

  • 10885862628534 ()

  • Height: 12 Millimeter
  • Size 3-5
03-CNB-PL-3512

  • Surgical tamp, reusable
3D/3D+ Punch Liner, Size 3-5, 10mm
Exactech, Inc.
03-CNB-PL-3510
In Commercial Distribution

  • 10885862628527 ()

  • Size 3-5
  • Height: 10 Millimeter
03-CNB-PL-3510

  • Surgical tamp, reusable
3D/3D+ Punch Liner, Size 3-5, 8mm
Exactech, Inc.
03-CNB-PL-3508
In Commercial Distribution

  • 10885862628510 ()

  • Height: 8 Millimeter
  • Size 3-5
03-CNB-PL-3508

  • Surgical tamp, reusable
PATELLAR DRILL GUIDE, 32/35, DOUBLE-ENDED
Exactech, Inc.
201-60-10
In Commercial Distribution

  • 10885862044167 ()

  • 32/35
201-60-10

  • Surgical drill guide, reusable
VASCULAR CLAMP DELICATE DOUBLE ANGLED JAW ANGLED SHANK
SONTEC INSTRUMENTS, INC.
2100-010
In Commercial Distribution


  • Length: 6 Inch
  • 35° Jaw


  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
LOGIC POST. AUG. BLOCK TRIAL SZ 3-5, 15MM
Exactech, Inc.
02-011-06-0593
In Commercial Distribution

  • 10885862287502 ()

  • SIZE 3-5
  • Height: 15 Millimeter
02-011-06-0593

  • Knee femur prosthesis trial, reusable
LOGIC POST. AUG. BLOCK TRIAL SZ 3-5, 10MM
Exactech, Inc.
02-011-06-0592
In Commercial Distribution

  • 10885862287496 ()

  • SIZE 3-5
  • Height: 10 Millimeter
02-011-06-0592

  • Knee femur prosthesis trial, reusable
LOGIC DIST. AUG. BLOCK TRIAL SZ 3-5, 15MM
Exactech, Inc.
02-011-06-0493
In Commercial Distribution

  • 10885862287441 ()

  • SIZE 3-5
  • Height: 15 Millimeter
02-011-06-0493

  • Knee femur prosthesis trial, reusable
LOGIC DIST. AUG. BLOCK TRIAL SZ 3-5, 5MM
Exactech, Inc.
02-011-06-0491
In Commercial Distribution

  • 10885862287427 ()

  • Height: 5 Millimeter
  • SIZE 3-5
02-011-06-0491

  • Knee femur prosthesis trial, reusable
LOGIC POST. AUG. BLOCK TRIAL SZ 3-5, 5MM
Exactech, Inc.
02-011-06-0591
In Commercial Distribution

  • 10885862287489 ()

  • Height: 5 Millimeter
  • SIZE 3-5
02-011-06-0591

  • Knee femur prosthesis trial, reusable
LOGIC DIST. AUG. BLOCK TRIAL SZ 3-5, 10MM
Exactech, Inc.
02-011-06-0492
In Commercial Distribution

  • 10885862287434 ()

  • SIZE 3-5
  • Height: 10 Millimeter
02-011-06-0492

  • Knee femur prosthesis trial, reusable
No Description
BRM EXTREMITIES SRL
SIZE 35 RIGHT
In Commercial Distribution

  • 08057717550856 ()

  • 35 RIGHT
BRDNEWP3535R

  • Total metatarsophalangeal joint prosthesis, one-piece
No Description
BRM EXTREMITIES SRL
SIZE 35 LEFT
In Commercial Distribution

  • 08057717550849 ()

  • 35 LEFT
BRDNEWP3535L

  • Total metatarsophalangeal joint prosthesis, one-piece
No Description
Zimmer, Inc.
SSI007243
In Commercial Distribution

  • 00889024650589 ()

  • LONG 35
SSI007243

  • Orthopaedic prosthesis implantation positioning instrument, reusable
3D/3D+ Punch Liner, Size 3-5, 6mm
Exactech, Inc.
03-CNB-PL-3506
In Commercial Distribution

  • 10885862628503 ()

  • Size 3-5
  • Height: 6 Millimeter
03-CNB-PL-3506

  • Surgical tamp, reusable
PE-patella cemented
implantcast GmbH
42030335
In Commercial Distribution

  • 04048844036331 ()

  • 35 mm


  • Polyethylene patella prosthesis
AcrySof(R) Natural SINGLE-PIECE ACRYLICFOLDABLE IOL, UV WITH BLUE LIGHT FILTER,POSTERIOR CHAMBER LENS (IOL/PC), 13.0mm LENGTH,6.0mm BICONVEX OPTIC, PLANAR HAPTICS.
Alcon Laboratories, Inc.
SN60AT
In Commercial Distribution

  • 00380655094136 ()

  • Diopter 35
SN60AT.350

  • Posterior-chamber intraocular lens, pseudophakic
AcrySof(R) SINGLE-PIECE ACRYLIC FOLDABLE IOL,UV-ABSORBING POSTERIOR CHAMBER LENS (IOL/PC),13.0mm LENGTH, 6.0mm BICONVEX OPTIC, PLANARHAPTICS.
Alcon Laboratories, Inc.
SA60AT
In Commercial Distribution

  • 00380650049025 ()

  • Diopter 35
SA60AT.350

  • Posterior-chamber intraocular lens, pseudophakic
AZUR HydroPack 18
MICROVENTION INC.
45-880035
In Commercial Distribution

  • 00842429118061 ()

  • 35 cm
45-880035

  • Non-neurovascular embolization coil
UTERINE, SIMS, NO. 16, 40 MM TIP
KLS-Martin L.P.
32-927-40-07
In Commercial Distribution

  • 00888118055408 ()

  • 35 CM


  • Intrauterine curette, manual
VASCULAR CLAMP DELICATE DOUBLE ANGLED JAW ANGLED SHANK
SONTEC INSTRUMENTS, INC.
2100-010
Not in Commercial Distribution

  • B09921000100 ()

  • 35° Jaw
  • Length: 6 Inch


  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
No Description
Biomet Orthopedics, LLC
902964
In Commercial Distribution

  • 70887868581112 ()
  • 00887868581113 ()

  • 35 mm
902964

  • Suturing needle, single-use
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