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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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Avaline Medical NJ LLC - 00810077210031

Washable Underpads 36"x72" x2
Avaline Medical NJ Limited Liability Company
ZRUP3672R X 2 +IG
In Commercial Distribution

  • 00810077212509 ()
  • 00810077210031 ()
ZRUP3672R X 2 +IG

  • Absorbent underpad, non-antimicrobial, reusable

AltaTrack - 00884838099340

Imaging device with FORS technology intended to aid the positioning and navigation of a connected AltaTrack Guidewire and optionally a catheter during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real time of the connected AltaTrack Guidewire, and of an endovascular catheter, when combined with an AltaTrack 3D Hub.
Philips Medical Systems Nederland B.V.
AltaTrack equipment
Not in Commercial Distribution

  • 00884838099340 ()
4322 070 2535 X

  • Diagnostic x-ray digital imaging system workstation application software

TCMzone HuoTuo - 00860014142413

Disposable acupuncture needle, 0.20mm × 30mm (#36), with spring handle and guide tube. Sterile, single-use. Packaged 10 needles per blister, 100 blisters per box (1000 needles total).
TCMZone, LLC
T1K-0.20mm x 30mm
In Commercial Distribution

  • 00860014142475 ()
  • 00860014142413 ()
T1K-0.20mm x 30mm (#36)

  • Acupuncture needle, single-use

TCMzone HuoTuo - 00860014142451

Disposable acupuncture needle, 0.25mm × 40mm (#32), with spring handle and guide tube. Sterile, single-use. Packaged 10 needles per blister, 100 blisters per box (1000 needles total).
TCMZone, LLC
TIK-0.25mm x 40mm
In Commercial Distribution

  • 00860014142499 ()
  • 00860014142451 ()
TIK-0.25mm x 40mm (#32)

  • Acupuncture needle, single-use

TCMzone HuoTuo - 00860014142444

Disposable acupuncture needle, 0.22mm × 40mm (#34), with spring handle and guide tube. Sterile, single-use. Packaged 10 needles per blister, 100 blisters per box (1000 needles total).
TCMZone, LLC
TIK-0.22mm x 40mm
In Commercial Distribution

  • 00860014142482 ()
  • 00860014142444 ()
TIK-0.22mm x 40mm (#34)

  • Acupuncture needle, single-use

TCMzone HuoTuo - 00860014142437

Disposable acupuncture needle, 0.20mm × 40mm (#36), with spring handle and guide tube. Sterile, single-use. Packaged 10 needles per blister, 100 blisters per box (1000 needles total).
TCMZone, LLC
T1K-0.20mm x 40mm
In Commercial Distribution

  • 00860014142475 ()
  • 00860014142437 ()
T1K-0.20mm x 40mm (#36)

  • Acupuncture needle, single-use

GAS SAMPLING LINE 120'X.060'X.112' M/M - 00859290006335

Truer Medical Gas Sampling Lines are manufactured to the highest quality standards using medical-grade materials. Standard luer connection ensures secure fit
TRUER MEDICAL, INC.
90169
In Commercial Distribution

  • 00859290006335 ()
  • 10859290006332 ()
90169

  • Gas-sampling/monitoring respiratory tubing, single-use

GAS SAMPLING LINE 120' X .050' X .112' M/M - 00859290006328

Truer Medical Gas Sampling Lines are manufactured to the highest quality standards using medical-grade materials. Standard luer connection ensures secure fit
TRUER MEDICAL, INC.
90158
In Commercial Distribution

  • 10859290006325 ()
  • 00859290006328 ()
  • 20859290006322 ()
  • 30859290006329 ()
90158

  • Gas-sampling/monitoring respiratory tubing, single-use

GAS SAMPLING LINE 120'x.050'x.108' M/F - 00859290006304

Truer Medical Gas Sampling Lines are manufactured to the highest quality standards using medical-grade materials. Standard luer connection ensures secure fit
TRUER MEDICAL, INC.
90151
In Commercial Distribution

  • 10859290006301 ()
  • 00859290006304 ()
  • 20859290006308 ()
  • 30859290006305 ()
90151

  • Gas-sampling/monitoring respiratory tubing, single-use

Gas Sampling Line 120'X.050'x.108' M/M - 00859290006298

Truer Medical Gas Sampling Lines are manufactured to the highest quality standards using medical-grade materials. Standard luer connection ensures secure fit
TRUER MEDICAL, INC.
90150
In Commercial Distribution

  • 10859290006295 ()
  • 00859290006298 ()
  • 20859290006292 ()
  • 30859290006299 ()
  • 40859290006296 ()
90150

  • Gas-sampling/monitoring respiratory tubing, single-use

Gas Sampling Line 120'x.040'x.112' M/M - 00859290006281

Truer Medical Gas Sampling Lines are manufactured to the highest quality standards using medical-grade materials. Standard luer connection ensures secure fit
TRUER MEDICAL, INC.
90148
In Commercial Distribution

  • 10859290006288 ()
  • 00859290006281 ()
90148

  • Gas-sampling/monitoring respiratory tubing, single-use

Gas Sampling Line 120'x.048'x.108' M/F - 00859290006274

Truer Medical Gas Sampling Lines are manufactured to the highest quality standards using medical-grade materials. Standard luer connection ensures secure fit
TRUER MEDICAL, INC.
90101
In Commercial Distribution

  • 20859290006278 ()
  • 00859290006274 ()
  • 10859290006271 ()
90101

  • Gas-sampling/monitoring respiratory tubing, single-use

RegenaVate™ Formable DBM, 1cm x 4cm x 0.5cm, 2cc - 00854095006801

Formable DBM, 1cm x 4cm x 0.5cm, 2cc
Rti Surgical, Inc.
ZR0302
In Commercial Distribution

  • 00854095006801 ()
001510Z

  • Bone matrix implant, human-derived

RegenaVate™ Formable DBM, 1cm x 2cm x 0.5cm, 1cc - 00854095006795

Formable DBM, 1cm x 2cm x 0.5cm, 1cc
Rti Surgical, Inc.
ZR0301
In Commercial Distribution

  • 00854095006795 ()
001505Z

  • Bone matrix implant, human-derived

RegenaVate™ Formable DBM, 1cm x 1cm x 0.5cm, 0.5cc - 00854095006788

Formable DBM, 1cm x 1cm x 0.5cm, 0.5cc
Rti Surgical, Inc.
ZR0305
In Commercial Distribution

  • 00854095006788 ()
001504Z

  • Bone matrix implant, human-derived

MaxFuse,VBR, 12 (D) x 14 (W) x 38 (H) - 00846468056391

12 (D) x 14 (W) x 38 (H)
Pioneer Surgical Technology, Inc.
62-1517-65
Not in Commercial Distribution

  • 00846468056391 ()
62-1517-65

  • Vertebral body prosthesis

MaxFuse,VBR, 12 (D) x 14 (W) x 37 (H) - 00846468056377

12 (D) x 14 (W) x 37 (H)
Pioneer Surgical Technology, Inc.
62-1517-63
Not in Commercial Distribution

  • 00846468056377 ()
62-1517-63

  • Vertebral body prosthesis

MaxFuse,VBR, 12 (D) x 14 (W) x 36 (H) - 00846468056353

No Description
Pioneer Surgical Technology, Inc.
62-1517-61
Not in Commercial Distribution

  • 00846468056353 ()


  • Vertebral body prosthesis

MaxFuse,VBR, 12 (D) x 14 (W) x 35 (H) - 00846468056339

12 (D) x 14 (W) x 35 (H)
Pioneer Surgical Technology, Inc.
62-1517-59
Not in Commercial Distribution

  • 00846468056339 ()
62-1517-59

  • Vertebral body prosthesis

MaxFuse,VBR, 12 (D) x 14 (W) x 34 (H) - 00846468056315

12 (D) x 14 (W) x 34 (H)
Pioneer Surgical Technology, Inc.
62-1517-57
Not in Commercial Distribution

  • 00846468056315 ()
62-1517-57

  • Vertebral body prosthesis

MaxFuse,VBR, 12 (D) x 14 (W) x 34 (H) - 00846468056308

12 (D) x 14 (W) x 34 (H)
Pioneer Surgical Technology, Inc.
62-1517-56
Not in Commercial Distribution

  • 00846468056308 ()
62-1517-56

  • Vertebral body prosthesis

MaxFuse,VBR, 12 (D) x 14 (W) x 33 (H) - 00846468056285

12 (D) x 14 (W) x 33 (H)
Pioneer Surgical Technology, Inc.
62-1517-54
Not in Commercial Distribution

  • 00846468056285 ()
62-1517-54

  • Vertebral body prosthesis

MaxFuse,VBR, 12 (D) x 14 (W) x 32 (H) - 00846468056261

12 (D) x 14 (W) x 32 (H)
Pioneer Surgical Technology, Inc.
62-1517-52
Not in Commercial Distribution

  • 00846468056261 ()
62-1517-52

  • Vertebral body prosthesis

MaxFuse,VBR, 12 (D) x 14 (W) x 31 (H) - 00846468056247

12 (D) x 14 (W) x 31 (H)
Pioneer Surgical Technology, Inc.
62-1517-50
Not in Commercial Distribution

  • 00846468056247 ()
62-1517-50

  • Vertebral body prosthesis

MaxFuse,VBR, 12 (D) x 14 (W) x 30 (H) - 00846468056223

12 (D) x 14 (W) x 30 (H)
Pioneer Surgical Technology, Inc.
62-1517-48
Not in Commercial Distribution

  • 00846468056223 ()
62-1517-48

  • Vertebral body prosthesis

MaxFuse,VBR, 12 (D) x 14 (W) x 26 (H) - 00846468056155

12 (D) x 14 (W) x 26 (H)
Pioneer Surgical Technology, Inc.
62-1517-41
Not in Commercial Distribution

  • 00846468056155 ()
62-1517-41

  • Vertebral body prosthesis

MaxFuse,VBR, 12 (D) x 14 (W) x 25 (H) - 00846468056131

VBR, 12 (D) x 14 (W) x 25 (H)
Pioneer Surgical Technology, Inc.
62-1517-39
Not in Commercial Distribution

  • 00846468056131 ()
62-1517-39

  • Vertebral body prosthesis

MaxFuse,VBR, 12 (D) x 14 (W) x 24 (H) - 00846468056117

VBR, 12 (D) x 14 (W) x 24 (H)
Pioneer Surgical Technology, Inc.
62-1517-37
Not in Commercial Distribution

  • 00846468056117 ()
62-1517-37

  • Vertebral body prosthesis

MaxFuse,VBR, 12 (D) x 14 (W) x 24 (H) - 00846468056100

12 (D) x 14 (W) x 24 (H)
Pioneer Surgical Technology, Inc.
62-1517-36
Not in Commercial Distribution

  • 00846468056100 ()
62-1517-36

  • Vertebral body prosthesis

MaxFuse,VBR, 12 (D) x 14 (W) x 23 (H) - 00846468056094

VBR, 12 (D) x 14 (W) x 23 (H)
Pioneer Surgical Technology, Inc.
62-1517-35
Not in Commercial Distribution

  • 00846468056094 ()
62-1517-35

  • Vertebral body prosthesis
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