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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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Zirconia Translucent 16H16 (9 pieces) - D800ZRAB1039

No Description
ZIRKONZAHN SRL
ZRAB1039
In Commercial Distribution

  • D800ZRAB1039 ()


  • Dental bridge, ceramic

Zirconia Translucent 9 (2 pieces) - D800ZRAB0501

Content: 2 pieces Height: 16 mm Translucent zirconia for single crowns to large bridges (reduced structures for veneering with ceramics)
ZIRKONZAHN SRL
ZRAB0501
In Commercial Distribution

  • D800ZRAB0501 ()


  • Dental bridge, ceramic

Retrax Retraction Cord 9/1 - 00310866000626

Untreated Twisted Gingival Retraction Cord, 100 inches, Size: 9/1
PASCAL COMPANY, INC.
07910
In Commercial Distribution

  • 00310866000626 ()
07910

  • Gingival retraction cord, non-medicated

Racord Retraction Cord 9/1 - 00310866000541

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

  • 00310866000541 ()
07710

  • Gingival retraction cord, medicated

Pascord Retraction Cord 9/1 - 00310866000503

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

9'' DUAL ADJUSTMENT BACK SUP - 00609271051386

Extra-large
DARCO INTERNATIONAL, INC.
232-0010-60
In Commercial Distribution

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

  • Lumbar spine orthosis

9'' DUAL ADJUSTMENT BACK SUP - 00609271051379

Large
DARCO INTERNATIONAL, INC.
232-0010-50
In Commercial Distribution

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

  • Lumbar spine orthosis

9'' DUAL ADJUSTMENT BACK SUP - 00609271051355

Medium
DARCO INTERNATIONAL, INC.
232-0010-40
In Commercial Distribution

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

  • Lumbar spine orthosis

9'' DUAL ADJUSTMENT BACK SUP - 00609271051331

Small
DARCO INTERNATIONAL, INC.
232-0010-30
In Commercial Distribution

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

  • Lumbar spine orthosis

Gel Sheet, 4.5" x 9" - 00614464905650

No Description
Silipos Holding LLC
90565
In Commercial Distribution

  • 00614464905650 ()


  • Custom-made cushion

PANACEA CONVERTIBLE 9 CELL MATTRESS - 00845699007998

No Description
SIZEWISE RENTALS, L.L.C.
PANACEA CONVERTIBLE 9 CELL MATTRESS
In Commercial Distribution

  • 00845699007998 ()


  • Alternating-pressure bed mattress

Tapia adenoid spatula, 9 holes - 04250381888728

No Description
Spiggle & Theis Medizintechnik GmbH
40-510-01
In Commercial Distribution

  • 04250381888728 ()
40-510-01

  • General-purpose surgical spatula

SMARTFIT FINAL HYBRID DENTURE - 9 - 00810126042057

No Description
HIOSSEN, INC.
FNLHYD09
In Commercial Distribution

  • 00810126042057 ()


  • Dental implant suprastructure, temporary, preformed, single-use

StarGuard Suture Retention Plates - 9" - 00810805000231

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

9 Hole VL Tibia Plate - 00812926025506

No Description
Trilliant Surgical, LLC
300-62-002
In Commercial Distribution

  • 00812926025506 ()

  • 9 Hole VL Tibia Plate


  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

CERVICAL COIL N.9 SERV - 08056304452887

Coil for G-scan Brio Service
ESAOTE SPA
131000401
In Commercial Distribution

  • 08056304452887 ()


  • MRI system coil, radio-frequency

CERVICAL COIL N.9 SERV - 08056304452832

No Description
ESAOTE SPA
9102693101
In Commercial Distribution

  • 08056304452832 ()


  • MRI system coil, radio-frequency

BD SiteRite 9 Ultrasound System - 00801741227707

BD SiteRite 9 Ultrasound System (Refurbished)
Bard Access Systems, Inc.
9770800R
In Commercial Distribution

  • 00801741227707 ()
9770800R

  • General-purpose ultrasound imaging system

BD SiteRite 9 Ultrasound System - 00801741226274

BD SiteRite 9 Cue Linear Probe
Bard Access Systems, Inc.
9770803
In Commercial Distribution

  • 00801741226274 ()
9770803

  • General-purpose ultrasound imaging system

LAP CHOLE KIT 9 GK - 20607915123646

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

TOTAL 5mm SOLUTION KIT 9 - 20607915127255

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

SANDBAG 3LB 9 X 7IN - 00733657244243

No Description
ALIMED, INC.
9-500
In Commercial Distribution

  • 00733657244243 ()
2970017440

  • Traction weight

Provox LaryTube 9/55, Fenestrated - 07331791002533

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 9/36, Fenestrated - 07331791002519

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

9" ABD BINDER 46-62" BAGGED - 50610570190558

No Description
Bird & Cronin, LLC
90001762
In Commercial Distribution

  • 50610570190558 ()
  • 00610570190553 ()


  • Abdominal binder, single-use

9" COMFOR ABD BINDER 55-72" - 50610570002233

No Description
Bird & Cronin, LLC
08140372
In Commercial Distribution

  • 50610570002233 ()
  • 00610570002238 ()


  • Abdominal binder, single-use

9" COMFOR ABD BINDER 46-62" - 50610570002226

No Description
Bird & Cronin, LLC
08140362
In Commercial Distribution

  • 50610570002226 ()
  • 00610570002221 ()


  • Abdominal binder, single-use

SapphireCool Light Guide 9 mm - 07290109141008

No Description
LUMENIS LTD.
SapphireCool Light Guide 9 mm
Not in Commercial Distribution

  • 07290109141008 ()


  • Multi-modality skin surface treatment system

ASSY,Reag.Disp.Card,PrepKit 9,BenchMark - 07613336125410

No Description
Ventana Medical Systems, Inc.
05251427001
In Commercial Distribution

  • 07613336125410 ()
05251427001

  • Assay container IVD, single-use

Persona® - 00889024560383

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

Persona® - 00889024560369

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

Persona® - 00889024560345

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

Persona® - 00889024560277

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

Persona® - 00889024560253

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

Persona® - 00889024560239

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 - 00889989017441

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 - 00889989017434

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 - 00192896097315

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 - 00192896069305

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 - 00192896067585

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
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