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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Twisted Gingival Retraction Cord with Epinephrine, 72 inches, Size: 9/1
PASCAL COMPANY, INC.
07710
In Commercial Distribution

  • 00310866000541 ()
07710

  • Gingival retraction cord, medicated
Twisted Gingival Retraction cord with Aluminum Sulfate, 72 inches, Size: 9/1
PASCAL COMPANY, INC.
07610
In Commercial Distribution

  • 00310866000503 ()
07610

  • Gingival retraction cord, non-medicated
Extra-large
DARCO INTERNATIONAL, INC.
232-0010-60
In Commercial Distribution

  • 10609271051383 ()
  • 00609271051386 ()
  • 20609271051380 ()
232-0010-60

  • Lumbar spine orthosis
Large
DARCO INTERNATIONAL, INC.
232-0010-50
In Commercial Distribution

  • 20609271051373 ()
  • 00609271051379 ()
  • 10609271051376 ()
232-0010-50

  • Lumbar spine orthosis
Medium
DARCO INTERNATIONAL, INC.
232-0010-40
In Commercial Distribution

  • 20609271051359 ()
  • 00609271051355 ()
  • 10609271051352 ()
232-0010-40

  • Lumbar spine orthosis
Small
DARCO INTERNATIONAL, INC.
232-0010-30
In Commercial Distribution

  • 10609271051338 ()
  • 00609271051331 ()
  • 20609271051335 ()
232-0010-30

  • Lumbar spine orthosis
No Description
Silipos Holding LLC
90565
In Commercial Distribution

  • 00614464905650 ()


  • Custom-made cushion
No Description
SIZEWISE RENTALS, L.L.C.
PANACEA CONVERTIBLE 9 CELL MATTRESS
In Commercial Distribution

  • 00845699007998 ()


  • Alternating-pressure bed mattress
No Description
Spiggle & Theis Medizintechnik GmbH
40-510-01
In Commercial Distribution

  • 04250381888728 ()
40-510-01

  • General-purpose surgical spatula
No Description
HIOSSEN, INC.
FNLHYD09
In Commercial Distribution

  • 00810126042057 ()


  • Dental implant suprastructure, temporary, preformed, single-use
For the temporary, external anchoring of sutures and prevention of suture pull through.
PRESERVATION SOLUTIONS INC
SG-9
In Commercial Distribution

  • 00810805000231 ()


  • Suture retention device
No Description
Trilliant Surgical, LLC
300-62-002
In Commercial Distribution

  • 00812926025506 ()

  • 9 Hole VL Tibia Plate


  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Coil for G-scan Brio Service
ESAOTE SPA
131000401
In Commercial Distribution

  • 08056304452887 ()


  • MRI system coil, radio-frequency
No Description
ESAOTE SPA
9102693101
In Commercial Distribution

  • 08056304452832 ()


  • MRI system coil, radio-frequency
BD SiteRite 9 Ultrasound System (Refurbished)
Bard Access Systems, Inc.
9770800R
In Commercial Distribution

  • 00801741227707 ()
9770800R

  • General-purpose ultrasound imaging system
BD SiteRite 9 Cue Linear Probe
Bard Access Systems, Inc.
9770803
In Commercial Distribution

  • 00801741226274 ()
9770803

  • General-purpose ultrasound imaging system
Kit Contains: CA090, DIRECT DRIVE LCA 3/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX C0R47, 12x100 Kii BALLOON BLUNT TIP 6/BX CTB33, 11X100 Kii SH BLD ZTHR 6/BX CTB12, 5x100 Kii SH BLD ZTHR DP 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK109-H
Not in Commercial Distribution

  • 20607915123646 ()


  • Laparoscopic access cannula, single-use
  • Tissue extraction bag
  • Ligation clip, metallic
Kit Contains: C0Q20, 5x100 Kii BALLOON BLUNT TIP 6/BX CFB12, 5x100 Kii SH BLD ADVFIX DP 10/BX CFS02, 5x100 Kii SLEEVE ADVFIX 12/BX CD003, 5mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK151
In Commercial Distribution

  • 20607915127255 ()


  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
No Description
ALIMED, INC.
9-500
In Commercial Distribution

  • 00733657244243 ()
2970017440

  • Traction weight
Provox LaryTube is a holder for devices in the Provox HME System intended for vocal and pulmonary rehabilitation after total laryngectomy. For patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. The Provox LaryTube is intended for single patient use. The Fenestrated model is made for use with a voice prosthesis. The Fenestrated model can be attached with a Provox TubeHolder or Provox LaryClips.
Atos Medical AB
7641
In Commercial Distribution

  • 07331791002533 ()

  • Lumen/Inner Diameter: 10.5 Millimeter
  • Outer Diameter: 13.5 Millimeter
  • Length: 55 Millimeter
7641

  • Tracheostomy tube, non-reinforced, non-customized, reusable
Provox LaryTube is a holder for devices in the Provox HME System intended for vocal and pulmonary rehabilitation after total laryngectomy. For patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. The Provox LaryTube is intended for single patient use. The Fenestrated model is made for use with a voice prosthesis. The Fenestrated model can be attached with a Provox TubeHolder or Provox LaryClips.
Atos Medical AB
7640
In Commercial Distribution

  • 07331791002519 ()

  • Lumen/Inner Diameter: 10.5 Millimeter
  • Outer Diameter: 13.5 Millimeter
  • Length: 36 Millimeter
7640

  • Tracheostomy tube, non-reinforced, non-customized, reusable
No Description
Bird & Cronin, LLC
90001762
In Commercial Distribution

  • 50610570190558 ()
  • 00610570190553 ()


  • Abdominal binder, single-use
No Description
Bird & Cronin, LLC
08140372
In Commercial Distribution

  • 50610570002233 ()
  • 00610570002238 ()


  • Abdominal binder, single-use
No Description
Bird & Cronin, LLC
08140362
In Commercial Distribution

  • 50610570002226 ()
  • 00610570002221 ()


  • Abdominal binder, single-use
No Description
LUMENIS LTD.
SapphireCool Light Guide 9 mm
Not in Commercial Distribution

  • 07290109141008 ()


  • Multi-modality skin surface treatment system
No Description
Ventana Medical Systems, Inc.
05251427001
In Commercial Distribution

  • 07613336125410 ()
05251427001

  • Assay container IVD, single-use
No Description
Zimmer, Inc.
42-5892-009-10
In Commercial Distribution

  • 00889024560383 ()

  • Sizes 7, 7+, 9, 9+ / G, H
42-5892-009-10

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
42-5892-007-10
In Commercial Distribution

  • 00889024560369 ()

  • Sizes 7, 7+, 9, 9+ / E, F
42-5892-007-10

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
42-5892-005-10
In Commercial Distribution

  • 00889024560345 ()

  • Sizes 7, 7+, 9, 9+ / C, D
42-5892-005-10

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
42-5891-009-10
In Commercial Distribution

  • 00889024560277 ()

  • Sizes 7, 7+, 9, 9+ / G, H
42-5891-009-10

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
42-5891-007-10
In Commercial Distribution

  • 00889024560253 ()

  • Sizes 7, 7+, 9, 9+ / E, F
42-5891-007-10

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
42-5891-005-10
In Commercial Distribution

  • 00889024560239 ()

  • Sizes 7, 7+, 9, 9+ / C, D
42-5891-005-10

  • Knee tibia prosthesis trial, reusable
ORTHOS CM 20 UL LATERAL TSP 9T 9A
ORMCO CORPORATION
454-6211
In Commercial Distribution

  • 10889989017448 ()
  • 00889989017441 ()

  • Slot Size 020, Torque 9, Angulation 9


  • Orthodontic bracket, metal
ORTHOS CM 20 UR LATERAL TSP 9T 9A
ORMCO CORPORATION
454-6210
In Commercial Distribution

  • 10889989017431 ()
  • 00889989017434 ()

  • Slot Size 020, Torque 9, Angulation 9


  • Orthodontic bracket, metal
RESANO BROWN FORCEPS DOUBLE ACTION TIP ROUND HANDLE COUNTER WEIGHT TITANIUM
SONTEC INSTRUMENTS, INC.
2601-303
In Commercial Distribution

  • 00192896097315 ()

  • Length: 10 Inch
  • 9 x 9 Teeth
  • 2 Millimeter Tip
2601-303

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
RESANO BROWN FORCEPS DOUBLE ACTION STRAIGHT TIPS ROUND HANDLE TITANIUM COUNTER WEIGHT
SONTEC INSTRUMENTS, INC.
2601-305
In Commercial Distribution

  • 00192896069305 ()

  • 9 x 9 Teeth
  • 2 Millimeter Jaw
  • Length: 12 Inch
2601-305

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
RESANO BROWN FORCEPS DOUBLE ACTION TITANIUM COUNTER WEIGHT
SONTEC INSTRUMENTS, INC.
2600-383
In Commercial Distribution

  • 00192896067585 ()

  • 2 Millimeter Tip
  • 9 x 9 Teeth
  • Length: 8.25 Inch
2600-383

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
ORTHOSCM BKT-UL LAT -4.5R 9T 9a 22 W/HK
ORMCO CORPORATION
455-1211
In Commercial Distribution

  • 10889989008682 ()
  • 00889989008685 ()

  • Slot size 022, Torque 9, Angulation 9


  • Orthodontic bracket, metal
ORTHOSCM BKT-UR LAT -4.5R 9T 9a 22 W/HK
ORMCO CORPORATION
455-1210
In Commercial Distribution

  • 10889989008675 ()
  • 00889989008678 ()

  • Slot size 022, Torque 9, Angulation 9


  • Orthodontic bracket, metal
ORTHOS C/M - UL LAT 9T 9A 22
ORMCO CORPORATION
455-0213
In Commercial Distribution

  • 10889989008361 ()
  • 00889989008364 ()

  • Slot size 022, Torque 9, Angulation 9


  • Orthodontic bracket, metal
ORTHOS C/M - UR LAT 9T 9A 22
ORMCO CORPORATION
455-0212
In Commercial Distribution

  • 10889989008354 ()
  • 00889989008357 ()

  • Slot size 022, Torque 9, Angulation 9


  • Orthodontic bracket, metal
ORTHOS CM BKT-UL LAT -4.5R 9T 9A 022
ORMCO CORPORATION
455-0211
In Commercial Distribution

  • 10889989008347 ()
  • 00889989008340 ()

  • Slot size 022, Torque 9, Angulation 9


  • Orthodontic bracket, metal
ORTHOS CM BKT-UR LAT -4.5R 9T 9A 022
ORMCO CORPORATION
455-0210
In Commercial Distribution

  • 10889989008330 ()
  • 00889989008333 ()

  • Slot size 022, Torque 9, Angulation 9


  • Orthodontic bracket, metal
ORTHOSCM BKT-UL LAT -4.5R 9T 9a 18 W/HK
ORMCO CORPORATION
454-1211
In Commercial Distribution

  • 10889989008088 ()
  • 00889989008081 ()

  • Slot size 018, Torque 9, Angulation 9


  • Orthodontic bracket, metal
ORTHOSCM BKT-UR LAT -4.5R 9T 9a 18 W/HK
ORMCO CORPORATION
454-1210
In Commercial Distribution

  • 10889989008071 ()
  • 00889989008074 ()

  • Slot size 018, Torque 9, Angulation 9


  • Orthodontic bracket, metal
ORTHOS C/M - UL LAT 9T 9A 18
ORMCO CORPORATION
454-0213
In Commercial Distribution

  • 10889989007760 ()
  • 00889989007763 ()

  • Slot size 018, Torque 9, Angulation 9


  • Orthodontic bracket, metal
ORTHOS C/M - UR LAT 9T 9A 18
ORMCO CORPORATION
454-0212
In Commercial Distribution

  • 10889989007753 ()
  • 00889989007756 ()

  • Slot size 018, Torque 9, Angulation 9


  • Orthodontic bracket, metal
ORTHOS CM BKT-UL LAT -4.5R 9T 9A 018
ORMCO CORPORATION
454-0211
In Commercial Distribution

  • 10889989007746 ()
  • 00889989007749 ()

  • Slot size 018, Torque 9, Angulation 9


  • Orthodontic bracket, metal
ORTHOS CM BKT-UR LAT -4.5R 9T 9A 018
ORMCO CORPORATION
454-0210
In Commercial Distribution

  • 10889989007739 ()
  • 00889989007732 ()

  • Slot size 018, Torque 9, Angulation 9


  • Orthodontic bracket, metal
9 FRENCH, 9 INCH LENGTH, TEARDROP TIP, WITH 90 DEGREE BEND NORTH, POLISHED FINISHED
PMT CORPORATION
3201-09T-09-095-PF
In Commercial Distribution

  • 00650551004516 ()


  • Surgical irrigation/aspiration handpiece, reusable
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