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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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Juzo Suspension Sleeve - 00640095025290

Suspension Sleeve, 14" / 35 cm , 9
Julius Zorn, Inc.
3232DG 9
In Commercial Distribution

  • 00640095025290 ()
02529

  • Tubular support bandage, non-latex, reusable

Juzo Suspension Sleeve - 00640095025184

Suspension Sleeve, 12" / 30 cm , 9
Julius Zorn, Inc.
3232DF 9
In Commercial Distribution

  • 00640095025184 ()
02518

  • Tubular support bandage, non-latex, reusable

SPECWELL - 04582697820032

No Description
SPECWELL CORPORATION
3x 9
In Commercial Distribution

  • 04582697820032 ()


  • Indirect monocular ophthalmoscope, electrically-powered

McKesson - 00612479252912

Chisel Blade Carb MMC #9 Ster
MCKESSON MEDICAL-SURGICAL INC.
MMC#9
In Commercial Distribution

  • 00612479252929 ()
  • 00612479252912 ()
  • 00612479252905 ()


  • Scalpel, single-use

Fisherbrand - 00613647002469

PRP 1.5X5 LATX FREE 48/CS
FISHER SCIENTIFIC COMPANY L.L.C.
KZ401.5-NO.9
In Commercial Distribution

  • 20613647002463 ()
  • 00613647002469 ()
  • 10613647002466 ()
22363113

  • Non-adhesive device retention bandage

Fisherbrand - 00613647002384

PRP 1X5 LATX FREE 30/CS
FISHER SCIENTIFIC COMPANY L.L.C.
KZ401-NO.9
In Commercial Distribution

  • 20613647002388 ()
  • 00613647002384 ()
  • 10613647002381 ()
22363102

  • Non-adhesive device retention bandage

E Supreme - 00643293000373

E Supreme Breast Protehsis Size 9
TRULIFE LIMITED
509 9
In Commercial Distribution

  • 00643293000373 ()


  • External breast prosthesis

Sublime Arís - 00643293026311

Sublime Arís Size 9
TRULIFE LIMITED
151 9
In Commercial Distribution

  • 00643293026311 ()


  • External breast prosthesis

Joint Jack Company - 00858534005066

No Description
Joint Jack Company
Joint-Spring 9"
In Commercial Distribution

  • 00858534005066 ()
1204

  • Hand/finger splint, single-use

Hu-Friedy MFG Co., LLC. - 10889950030650

#8/9 Orban DE Hoe Scaler
HU-FRIEDY MFG. CO., LLC
SO8/9
In Commercial Distribution

  • 10889950030650 ()


  • Periodontal hoe

Neoscope - 00851545007623

NEOFLEX-FLEXIBLE VIDEO URETEROSCOPE
PROSURG INC
NFU 9
In Commercial Distribution

  • 00851545007623 ()
  • 10851545007620 ()

  • Catheter Gauge: 9.0 French


  • Flexible video ureteroscope, reusable

Hu-Friedy MFG Co., LLC - 10889950097158

#7/9 McCall DE Hoe Scaler
HU-FRIEDY MFG. CO., LLC
SM7/9
In Commercial Distribution

  • 10889950097158 ()


  • Periodontal hoe

HairMax - 00856823006251

Hair Growth Laser Light Device - Low Level Laser Therapy (LLLT)
Lexington International, LLC
Ultima 9
In Commercial Distribution

  • 00856823006251 ()


  • Hair growth laser device

HYPE stem - 03662200017928

No Description
SOC ETUDES RECHERCHES FABRICATION
COEH 9
In Commercial Distribution

  • 03662200017928 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

HYPE stem - 03662200020577

No Description
SOC ETUDES RECHERCHES FABRICATION
RH606 9
In Commercial Distribution

  • 03662200020577 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

IQ Dental - 00816519020732

IQ Dental Self Seal Sterilization Pouches 3.5X9 Box/200
IQ DENTAL SUPPLY LLC
NRG-SP35/9
In Commercial Distribution

  • 00816519020732 ()


  • Sterilization packaging, single-use

ZOLL DENTAL - 00840105222545

Heidbrink #8/9
Zoll-Dental
RT-HB8/9
In Commercial Distribution

  • 00840105222545 ()


  • Dental elevator, tooth/root

ZOLL-DENTAL - 00840105214304

Orban #8/9
Zoll-Dental
S-ORB8/9
In Commercial Distribution

  • 00840105214304 ()


  • Manual dental scaler, reusable

ZOLL-DENTAL - 00840105214090

McCall #7/9
Zoll-Dental
S-MC7/9
In Commercial Distribution

  • 00840105214090 ()


  • Manual dental scaler, reusable

ORLIMAN - 08435025919686

No Description
ORLIMAN S.L.U.
D-111#9
In Commercial Distribution

  • 08435025919686 ()


  • Abdominal hernia truss, reusable

ORLIMAN - 08435025914827

No Description
ORLIMAN S.L.U.
B-110#9
In Commercial Distribution

  • 08435025914827 ()


  • Abdominal hernia truss, reusable

Atos Medical - 00817126020603

2010-056 Laryngectomy Pulmonary Kit 9/36 With Provox® Standard LaryTube™ and SolaTone® Electrolarynx
ATOS MEDICAL INC.
9/36
Not in Commercial Distribution

  • 00817126020603 ()
2010-056

  • Transcervical artificial larynx
  • Airway device cleaning utensil, noninvasive, reusable
  • Tracheostoma shower shield
  • Tracheostomy tube neck holder, reusable
  • Tracheostomy tube, non-reinforced, non-customized, reusable
  • Tracheostoma protective filter

Atos Medical - 00817126020528

Laryngectomy Pulmonary Kit 9/55 With Provox® Standard LaryTube™ and Liberty™ Electrolarynx
ATOS MEDICAL INC.
9/55
Not in Commercial Distribution

  • 00817126020528 ()
2010C-07E6

  • Tracheoesophageal speech valve, indwelling

Atos Medical - 00817126020511

Laryngectomy Pulmonary Kit 9/55 With Provox® LaryTube™ with Ring and Provox® OptiDerm™ Adhesive
ATOS MEDICAL INC.
9/55
Not in Commercial Distribution

  • 00817126020511 ()
2010-27

  • Tracheoesophageal speech valve, indwelling

Atos Medical - 00817126020436

Laryngectomy Pulmonary Kit With Standard Provox® LaryTube™ 9/27
ATOS MEDICAL INC.
9/27
Not in Commercial Distribution

  • 00817126020436 ()
2010-05

  • Tracheoesophageal speech valve, indwelling

Atos Medical - 00817126020412

Laryngectomy Pulmonary Kit 9/55 With Provox® Standard LaryTube™ and Servox™ Electrolarynx
ATOS MEDICAL INC.
9/55
Not in Commercial Distribution

  • 00817126020412 ()
2010-07E4

  • Tracheoesophageal speech valve, indwelling

Atos Medical - 00817126020375

Laryngectomy Pulmonary Kit 9/55 With Provox® Standard LaryTube™ and TruTone™ Electrolarynx
ATOS MEDICAL INC.
9/55
Not in Commercial Distribution

  • 00817126020375 ()
2010-07E1

  • Tracheoesophageal speech valve, indwelling

Atos Medical - 00817126020368

Laryngectomy Pulmonary Kit 9/36 With Provox® Standard LaryTube™ and TruTone™ Electrolarynx
ATOS MEDICAL INC.
9/36
Not in Commercial Distribution

  • 00817126020368 ()
2010-06E1

  • Tracheoesophageal speech valve, indwelling

Atos Medical - 00817126020344

Laryngectomy Pulmonary Kit 9/55 With Provox® Standard LaryTube™
ATOS MEDICAL INC.
9/55
Not in Commercial Distribution

  • 00817126020344 ()
2010C3-02

  • Tracheoesophageal speech valve, indwelling

Atos Medical - 00817126020306

Laryngectomy Pulmonary Kit 9/55 With Provox® Standard LaryTube™ and Liberty™ Electrolarynx
ATOS MEDICAL INC.
9/55
Not in Commercial Distribution

  • 00817126020306 ()
2010C4-07E6

  • Tracheoesophageal speech valve, indwelling

Atos Medical - 00817126020269

Laryngectomy Pulmonary Kit 9/36 With Provox® Standard LaryTube™ and Liberty™ Electrolarynx
ATOS MEDICAL INC.
9/36
Not in Commercial Distribution

  • 00817126020269 ()
2010-06E6

  • Tracheoesophageal speech valve, indwelling

Atos Medical - 00817126020245

Laryngectomy Pulmonary Kit 9/55 With Provox® Standard LaryTube™ and LaryClips™
ATOS MEDICAL INC.
9/55
Not in Commercial Distribution

  • 00817126020245 ()
2010-02LC

  • Tracheoesophageal speech valve, indwelling

Atos Medical - 00817126020191

Laryngectomy Pulmonary Kit 9/36 With Provox® Fenestrated LaryTube™
ATOS MEDICAL INC.
9/36
Not in Commercial Distribution

  • 00817126020191 ()
2010-401

  • Tracheoesophageal speech valve, indwelling

Atos Medical - 00817126020160

Laryngectomy Pulmonary Kit With Standard Provox® LaryTube™ 9/36
ATOS MEDICAL INC.
9/36
Not in Commercial Distribution

  • 00817126020160 ()
2010-01

  • Tracheoesophageal speech valve, indwelling

Atos Medical - 00817126020146

Laryngectomy Pulmonary Kit 9/36 With Provox® Fenestrated LaryTube™
ATOS MEDICAL INC.
9/36
Not in Commercial Distribution

  • 00817126020146 ()
2010-40

  • Tracheoesophageal speech valve, indwelling

Atos Medical - 00817126020139

Laryngectomy Pulmonary Kit 9/55 With Provox® Fenestrated LaryTube™
ATOS MEDICAL INC.
9/55
Not in Commercial Distribution

  • 00817126020139 ()
2010-41

  • Tracheoesophageal speech valve, indwelling

Atos Medical - 00817126020122

Laryngectomy Pulmonary Kit 9/55 With Provox® Standard LaryTube™ and Liberty™ Electrolarynx
ATOS MEDICAL INC.
9/55
Not in Commercial Distribution

  • 00817126020122 ()
2010-07E6

  • Tracheoesophageal speech valve, indwelling

Atos Medical - 00817126020115

Laryngectomy Pulmonary Kit 9/55 W/ Provox Vega 17Fr 8mm, Guide Wire, and Provox Vega Plug
ATOS MEDICAL INC.
9/55
Not in Commercial Distribution

  • 00817126020115 ()
2012-07

  • Tracheoesophageal speech valve, indwelling

Atos Medical - 00817126020108

Laryngectomy Pulmonary Kit 9/55 With Provox® Standard LaryTube™
ATOS MEDICAL INC.
9/55
Not in Commercial Distribution

  • 00817126020108 ()
2010-02

  • Tracheoesophageal speech valve, indwelling

Atos Medical - 00817126020078

Laryngectomy Pulmonary Kit 9/55 - Fenestrated Provox Vega Puncture Set 20Fr 10mm
ATOS MEDICAL INC.
9/55
Not in Commercial Distribution

  • 00817126020078 ()
2045-41

  • Tracheoesophageal speech valve, indwelling
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