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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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Bioteque America, Inc. - 00810142350297

CUBE PESSARY (w/o), CU70 #9
Bioteque America, Inc.
CU9
In Commercial Distribution

  • 00810142350297 ()


  • Pelvic-organ-supporting pessary

Bioteque America, Inc. - 00810142350198

RING PESSARY (w), R4.00 S#9
Bioteque America, Inc.
Rs9
In Commercial Distribution

  • 00810142350198 ()


  • Pelvic-organ-supporting pessary

Bioteque America, Inc. - 00810142350099

RING PESSARY (w/o), R4.00 #9
Bioteque America, Inc.
R9
In Commercial Distribution

  • 00810142350099 ()


  • Pelvic-organ-supporting pessary

ASTRA TECH Implant System® - 07392532108235

OsseoSpeed® TX 4.5 - 9 mm
Dentsply Implants Manufacturing GmbH
24951
In Commercial Distribution

  • 07392532108235 ()
24951

  • Screw endosteal dental implant, two-piece

ASTRA TECH Implant System® - 07392532108181

OsseoSpeed® TX 5.0 - 9 mm
Dentsply Implants Manufacturing GmbH
24961
In Commercial Distribution

  • 07392532108181 ()
24961

  • Screw endosteal dental implant, two-piece

CRL Stat - 81781502509004

9 Panel Cup Drug Test, AMP-BAR-BZO-COC-MET-MTD-OPI-PCP-THC
CLINICAL REFERENCE LABORATORY, INC.
50900
Not in Commercial Distribution

  • 81781502509004 ()
50900

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

II Ring Retractor - 00810118342455

St. Mark’s Retractor 9" with Lip
Automated Medical Products Corp.
St. Mark’s Retractor 9" with Lip
In Commercial Distribution

  • 00810118342455 ()
1620 09 SS

  • Surgical retractor/retraction system blade, reusable

Iron Intern - 00810118340390

G50 Hibbs, 9 sharp teeth Blade
Automated Medical Products Corp.
G50 Hibbs, 9 sharp teeth
In Commercial Distribution

  • 00810118340390 ()
GB0050

  • Surgical retractor/retraction system blade, reusable

Traufix osteosynthesis, osteotomy, and arthrodesis devices - 07506494202553

3.5mm One-third tubular plate 9 holes
Fixier, S.A. de C.V.
016.09
In Commercial Distribution

  • 07506494202553 ()
016.09

  • Orthopaedic fixation plate, non-bioabsorbable

CoreTech - 00810113570785

830 Single Panel Knee Immobiliser 9"
VIVE HEALTH LLC
SUP3019BLK9
In Commercial Distribution

  • 10810113570782 ()
  • 00810113570785 ()


  • Knee support orthosis

Rabbit Monoclonal Anti-Human p53 Antibody, EP9 - 00810113060347

Rabbit Monoclonal Anti-Human p53 (9), concentrated
Epitomics Inc.
AC-010BULK
In Commercial Distribution

  • 00810113060347 ()


  • p53 tumour protein IVD, antibody

Vive - 00810113571768

Air and Gel Ankle Stirrup (9")
VIVE HEALTH LLC
SUP3026BLK9
In Commercial Distribution

  • 10810113571765 ()
  • 00810113571768 ()


  • Ankle/foot orthosis

MSI - 00810130205028

LEKSELL RONGEUR 9" 5X16MM 15DEG CVD)
Modern Surgical Instruments LLC
47-0487
In Commercial Distribution

  • 00810130205028 ()


  • Spinal rongeur

MSI - 00810130204168

LAMBOTTE OSTEOTOME 9" CVD. 3/4"
Modern Surgical Instruments LLC
46-0330
In Commercial Distribution

  • 00810130204168 ()


  • Orthopaedic osteotome

MSI - 00810130203628

BRUN CURETTE OVAL 9" #1 HOLL.HDL
Modern Surgical Instruments LLC
46-0566
In Commercial Distribution

  • 00810130203628 ()


  • Bone curette, reusable

MSI - 00810130203611

Brun Curette Oval 9" #0 Holl.Hdl
Modern Surgical Instruments LLC
46-0565
In Commercial Distribution

  • 00810130203611 ()


  • Bone curette, reusable

MSI - 00810130203604

Brun Curette Oval 9" #00 Holl.Hdl
Modern Surgical Instruments LLC
46-0564
In Commercial Distribution

  • 00810130203604 ()


  • Bone curette, reusable

MSI - 00810130203581

BRUN CURETTE 9" ANG. #6 HOLL.HDL.
Modern Surgical Instruments LLC
49-0118
In Commercial Distribution

  • 00810130203581 ()


  • Bone curette, reusable

MSI - 00810130203574

BRUN CURETTE 9" ANG. #5 HOLL.HDL
Modern Surgical Instruments LLC
49-0117
In Commercial Distribution

  • 00810130203574 ()


  • Bone curette, reusable

MSI - 00810130203550

BRUN CURETTE 9" ANG. #3 HOLL.HDL.
Modern Surgical Instruments LLC
49-0115
In Commercial Distribution

  • 00810130203550 ()


  • Bone curette, reusable

MSI - 00810130203154

NERVE ROOT RETR. OFFSET 9" 6MM
Modern Surgical Instruments LLC
55-0424
In Commercial Distribution

  • 00810130203154 ()


  • Nerve/vessel retractor

MSI - 00810130202805

STEIN.PIN(6)S.DMD.THR.9" .1875" 4.8MM
Modern Surgical Instruments LLC
71-0719
In Commercial Distribution

  • 00810130202805 ()


  • Orthopaedic bone wire

MSI - 00810130202720

HIBBS OSTEOTOME 9" STRAIGHT 5/8"
Modern Surgical Instruments LLC
46-0362
In Commercial Distribution

  • 00810130202720 ()


  • Orthopaedic osteotome

MSI - 00810130202539

Schlesinger Ivd Rong. 9" 5mm Str
Modern Surgical Instruments LLC
55-0691
In Commercial Distribution

  • 00810130202539 ()


  • Spinal rongeur

MSI - 00810130202522

Schlesinger Ivd Rong. 9" 3mm Str
Modern Surgical Instruments LLC
55-0690
In Commercial Distribution

  • 00810130202522 ()


  • Spinal rongeur

MSI - 00810130202218

LEKSELL RONGEUR 9" 8X16MM 15DEG CVD
Modern Surgical Instruments LLC
47-0490
In Commercial Distribution

  • 00810130202218 ()


  • Spinal rongeur

SL-PLUS - 07611996127119

SL-PLUS SDP WITH ANTEVERTED HOLE 9
Smith & Nephew, Inc.
75101972
In Commercial Distribution

  • 07611996127119 ()
75101972

  • Press-fit femoral stem prosthesis

MSI - 00810130206049

FUKUSHIMA SUCTION TUBES 6.25" 9 FR.
Modern Surgical Instruments LLC
42-0885
In Commercial Distribution

  • 00810130206049 ()


  • Surgical/emergency suction cannula, non-illuminating, reusable

MSI - 00810130205226

LAMBOTTE OSTEOTOME 9" STR. 3/4"
Modern Surgical Instruments LLC
46-0310
In Commercial Distribution

  • 00810130205226 ()


  • Orthopaedic osteotome

MSI - 00810130203635

BRUN CURETTE OVAL 9" #3 HOLL.HDL
Modern Surgical Instruments LLC
46-0568
In Commercial Distribution

  • 00810130203635 ()


  • Bone curette, reusable

MSI - 00810130203567

BRUN CURETTE 9" ANG. #4 HOLL.HDL
Modern Surgical Instruments LLC
49-0116
In Commercial Distribution

  • 00810130203567 ()


  • Bone curette, reusable

MSI - 00810130203543

BRUN CURETTE 9" ANG. #2 HOLL.HDL.
Modern Surgical Instruments LLC
49-0114
In Commercial Distribution

  • 00810130203543 ()


  • Bone curette, reusable

MSI - 00810130203536

BRUN CURETTE 9" ANG. #0 HOLL.HDL.
Modern Surgical Instruments LLC
49-0113
In Commercial Distribution

  • 00810130203536 ()


  • Bone curette, reusable

Unitron - 07613389413366

DX Stride M 9 (amber suede)
Unitron Hearing Division
050-6393-S2
In Commercial Distribution

  • 07613389413366 ()
050-6393-S2

  • Air-conduction hearing aid, behind-the-ear

Unitron - 07613389405958

DX Insera 9 W 312 Dir
Unitron Hearing Division
063-6224-01
In Commercial Distribution

  • 07613389405958 ()
063-6224-01

  • Air-conduction hearing aid, in-the-ear

Unitron - 07613389355376

DX Moxi Move R 9 (cinnamon)
Unitron Hearing Division
050-6253-Q9
In Commercial Distribution

  • 07613389355376 ()
050-6253-Q9

  • Air-conduction hearing aid, receiver-in-canal

Unitron - 07613389355369

DX Moxi Move R 9 (charcoal)
Unitron Hearing Division
050-6253-P8
In Commercial Distribution

  • 07613389355369 ()
050-6253-P8

  • Air-conduction hearing aid, receiver-in-canal

Unitron - 07613389355352

DX Moxi Move R 9 (pewter)
Unitron Hearing Division
050-6253-P7
In Commercial Distribution

  • 07613389355352 ()
050-6253-P7

  • Air-conduction hearing aid, receiver-in-canal

Unitron - 07613389355345

DX Moxi Move R 9 (platinum)
Unitron Hearing Division
050-6253-P6
In Commercial Distribution

  • 07613389355345 ()
050-6253-P6

  • Air-conduction hearing aid, receiver-in-canal

Unitron - 07613389355338

DX Moxi Move R 9 (espresso)
Unitron Hearing Division
050-6253-P4
In Commercial Distribution

  • 07613389355338 ()
050-6253-P4

  • Air-conduction hearing aid, receiver-in-canal

Unitron - 07613389355321

DX Moxi Move R 9 (amber)
Unitron Hearing Division
050-6253-P2
In Commercial Distribution

  • 07613389355321 ()
050-6253-P2

  • Air-conduction hearing aid, receiver-in-canal

Unitron - 07613389340457

DX Stride P R 9 (cinnamon)
Unitron Hearing Division
050-6265-Q9
In Commercial Distribution

  • 07613389340457 ()
050-6265-Q9

  • Air-conduction hearing aid, behind-the-ear

Unitron - 07613389340440

DX Stride P R 9 (charcoal)
Unitron Hearing Division
050-6265-P8
In Commercial Distribution

  • 07613389340440 ()
050-6265-P8

  • Air-conduction hearing aid, behind-the-ear

Unitron - 07613389340433

DX Stride P R 9 (pewter)
Unitron Hearing Division
050-6265-P7
In Commercial Distribution

  • 07613389340433 ()
050-6265-P7

  • Air-conduction hearing aid, behind-the-ear

Unitron - 07613389340426

DX Stride P R 9 (platinum)
Unitron Hearing Division
050-6265-P6
In Commercial Distribution

  • 07613389340426 ()
050-6265-P6

  • Air-conduction hearing aid, behind-the-ear

Unitron - 07613389340419

DX Stride P R 9 (espresso)
Unitron Hearing Division
050-6265-P4
In Commercial Distribution

  • 07613389340419 ()
050-6265-P4

  • Air-conduction hearing aid, behind-the-ear

Unitron - 07613389340167

DX Moxi Fit 9 (amber suede)
Unitron Hearing Division
050-6259-S2
In Commercial Distribution

  • 07613389340167 ()
050-6259-S2

  • Air-conduction hearing aid, receiver-in-canal

Unitron - 07613389340105

DX Moxi Fit 9 (amber beige)
Unitron Hearing Division
050-6259-P2
In Commercial Distribution

  • 07613389340105 ()
050-6259-P2

  • Air-conduction hearing aid, receiver-in-canal

Unitron - 07613389335576

DX Stride P R 9 (beige)
Unitron Hearing Division
050-6265-01
In Commercial Distribution

  • 07613389335576 ()
050-6265-01

  • Air-conduction hearing aid, behind-the-ear

Unitron - 07613389332841

DX Moxi Move R 9 (beige)
Unitron Hearing Division
050-6253-01
In Commercial Distribution

  • 07613389332841 ()
050-6253-01

  • Air-conduction hearing aid, receiver-in-canal
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