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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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CER-BN-84 - 00850023741028

Cervos 8GA Biopsy Needle P/N: 74356-01M Customer #: 12153
RANFAC CORP.
8GA X 4"
In Commercial Distribution

  • 00850023741028 ()
  • 10850023741025 ()
  • 20850023741022 ()

  • Needle Gauge: 8 Gauge
  • Length: 4 Inch
CER-BN-84

  • Bone marrow biopsy needle, single-use

CER-SUB-83N - 00850023741011

Cervos 8GA X 3" Delivery Cannula P/N: 74355-01M Customer #: 12153
RANFAC CORP.
8GA X 3"
In Commercial Distribution

  • 10850023741018 ()
  • 00850023741011 ()
  • 20850023741015 ()

  • Needle Gauge: 8 Gauge
  • Length: 3 Inch
CER-SUB-83N

  • Bone access cannula

EMAS (Eko Murmur Analysis Software) - 00850010298184

The Eko Murmur Analysis Software is intended to provide decision support to clinicians in their evaluation of patients’ heart sounds. The software analyzes heart sounds and phonocardiograms (and ECG signals, when available). The software will automatically detect murmurs that may be present, and the murmur timing and character, including S1, S2, innocent heart murmurs, structural heart murmurs, and the absence of a heart murmur.
Eko Devices, Inc.
Version 1.x
In Commercial Distribution

  • 00850010298184 ()
EMAS

  • Cardiopulmonary physiological parameter analysis software

Ranfac Biopsy Needle, 11GA, 4" - 00850075308002

RBN-114SS, F/G, Sterile PN 74441-01M Customer # 0019886
RANFAC CORP.
11GA X 4"
In Commercial Distribution

  • 00850075308002 ()
  • 10850075308009 ()
  • 20850075308006 ()

  • Length: 4 Inch
  • Needle Gauge: 11 Gauge
RBN-114SS

  • Bone marrow biopsy needle, single-use

POWERWAND™ XL - 00859821006810

Pouch, PW XL 3FR 6cm (US) for Kit (40351)
ACCESS SCIENTIFIC, LLC
3Fr x 6cm
In Commercial Distribution

  • 00859821006810 ()

  • Catheter Gauge: 3 French
  • Catheter Working Length: 6 Centimeter
40351

  • Vascular catheter introduction set, nonimplantable

CVC WAND XL - 00859821006711

The CVC WAND Safety Introducer with Valved Peelable Sheath
ACCESS SCIENTIFIC, LLC
7Fr X 6cm
In Commercial Distribution

  • 20859821006715 ()
  • 10859821006718 ()
  • 00859821006711 ()

  • Catheter Length: 6 Centimeter
  • Catheter Gauge: 7 French
93102

  • Vascular catheter introduction set, nonimplantable

CVC WAND - 00859821006704

The CVC WAND Safety Introducer with Valved Peelable Sheath
ACCESS SCIENTIFIC, LLC
7Fr X 6cm
In Commercial Distribution

  • 20859821006708 ()
  • 10859821006701 ()
  • 00859821006704 ()

  • Catheter Length: 6 Centimeter
  • Catheter Gauge: 7 French
93001

  • Vascular catheter introduction set, nonimplantable

RAN-16(2.8), F/G - 00858690006891

RAN-16(2.8)N5T, F/G PN 74048-03M
RANFAC CORP.
16GA x 2.8"
In Commercial Distribution

  • 20858690006895 ()
  • 10858690006898 ()
  • 00858690006891 ()

  • Length: 2.8 Inch
  • Needle Gauge: 16 Gauge
RAN-16(2.8)N5T

  • Bone access cannula

MC-RAN 13A, RJN-84 - 00858690006709

MC-RAN 13A, RJN-84 PN 74293-01M
RANFAC CORP.
13Gauge X 9CM
In Commercial Distribution

  • 20858690006703 ()
  • 10858690006706 ()
  • 00858690006709 ()

  • Length: 9 Centimeter
  • Needle Gauge: 13 Gauge
  • Needle Gauge: 8 Gauge
  • Length: 10 Centimeter
MC-RAN 13A

  • Bone access cannula

RBN-86, F/G, STERILE - 00858690006365

RBN-86 P/N 74225-01M
RANFAC CORP.
8GA X 6"
In Commercial Distribution

  • 00858690006365 ()
  • 10858690006362 ()
  • 20858690006369 ()

  • Length: 6 Inch
  • Needle Gauge: 8 Gauge
RBN-86

  • Bone marrow biopsy needle, single-use

Ranfac Aspiration Needle, 11GA X 150mm, RAN-1115N5T - 00858690006358

Ranfac Aspiration Needle, 11GA X 150mm RAN-1115N5T, Sterile, F/G P/N 74181-15M
RANFAC CORP.
11GA X 150mmN5T
In Commercial Distribution

  • 20858690006352 ()
  • 10858690006355 ()
  • 00858690006358 ()

  • Length: 150 Millimeter
  • Needle Gauge: 11 Gauge
RAN-1115N5T

  • Bone access cannula

Disc Cath - 00858690006242

Disc Cath P/N: 76102-02M
RANFAC CORP.
17GA X 6"
In Commercial Distribution

  • 10858690006249 ()
  • 00858690006242 ()
  • 20858690006246 ()

  • Length: 6 Inch
  • Needle Gauge: 17 Gauge
Disc Cath

  • Spinal needle, single-use

MC-RAN-11CSTS - 00858690006228

MC-RAN-11CSTS MAXX-REGEN Customer # 0018407 PN 74292-02M
RANFAC CORP.
11GA X 11CM
In Commercial Distribution

  • 00858690006228 ()
  • 10858690006225 ()
  • 20858690006222 ()

  • Length: 11 Centimeter
  • Needle Gauge: 11 Gauge
RB-REG-2

  • Bone access cannula

MC-RAN-11C - 00858690006211

MC-RAN-11C-MAXX REGEN PN 74292-01M Customer# 0018407
RANFAC CORP.
11GA X 9CM
In Commercial Distribution

  • 00858690006211 ()
  • 10858690006218 ()
  • 20858690006215 ()

  • Needle Gauge: 11 Gauge
  • Length: 9 Centimeter
RB-REG-1

  • Bone access cannula

NDL, RBN-114S, STERILE, F/G - 00858690006044

RBN-114S P/N 74092-01M
RANFAC CORP.
11GA X 4"
In Commercial Distribution

  • 20858690006048 ()
  • 10858690006041 ()
  • 00858690006044 ()

  • Length: 4 Inch
  • Needle Gauge: 11 Gauge
RBN-114S

  • Bone marrow biopsy needle, single-use

Patient Armor Sterilization Pouches - 00858653006005

Patient Armor Sterilization Pouches 2.75 x 10" - 200/Bx
AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.
2.75" x 10"
In Commercial Distribution

  • 00858653006005 ()
AMH-210

  • Sterilization packaging, single-use

TE X Lite Diagnostic Ultrasound System - 06903053003919

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
TE X Lite
In Commercial Distribution

  • 06903053003919 ()


  • General-purpose ultrasound imaging system

Twin Transfer Set - 04250273756005

For transition of irrigation solution.
Fresenius Kabi AG
1 D/X
In Commercial Distribution

  • 04250273756012 ()
  • 04250273756005 ()
2877001

  • Single-administration urethral drainage/irrigation catheter

Transfer Set - 04250273755787

For transition of irrigation solution.
Fresenius Kabi AG
2 D/X
In Commercial Distribution

  • 04250273755794 ()
  • 04250273755787 ()
2877201

  • Single-administration urethral drainage/irrigation catheter

Transfer Set - 04250273755749

For transition of irrigation solution.
Fresenius Kabi AG
4 D/X
In Commercial Distribution

  • 04250273755756 ()
  • 04250273755749 ()
2848021

  • Single-administration urethral drainage/irrigation catheter

Twin Transfer Set - 04250273755725

For transition of irrigation solution.
Fresenius Kabi AG
2 D/X
In Commercial Distribution

  • 04250273755725 ()
  • 04250273755732 ()
2848011

  • Electric infusion pump administration set, single-use

Hansol Medical Co. - 08809118710830

No Description
Hansol Medical Co.
0.40mm x 60mm
In Commercial Distribution

  • 08809118710830 ()
  • 18809118710837 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710793

No Description
Hansol Medical Co.
0.40mm x 40mm
In Commercial Distribution

  • 08809118710793 ()
  • 18809118710790 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710755

No Description
Hansol Medical Co.
0.40mm x 15mm
In Commercial Distribution

  • 08809118710755 ()
  • 18809118710752 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710731

No Description
Hansol Medical Co.
0.35mm x 120mm
In Commercial Distribution

  • 08809118710731 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710717

No Description
Hansol Medical Co.
0.35mm x 105mm
In Commercial Distribution

  • 08809118710717 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710694

No Description
Hansol Medical Co.
0.35mm x 90mm
In Commercial Distribution

  • 08809118710694 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710670

No Description
Hansol Medical Co.
0.35mm x 75mm
In Commercial Distribution

  • 08809118710670 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710656

No Description
Hansol Medical Co.
0.35mm x 60mm
In Commercial Distribution

  • 08809118710656 ()
  • 18809118710653 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710632

No Description
Hansol Medical Co.
0.35mm x 50mm
In Commercial Distribution

  • 08809118710632 ()
  • 18809118710639 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710618

No Description
Hansol Medical Co.
0.35mm x 40mm
In Commercial Distribution

  • 08809118710618 ()
  • 18809118710615 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710595

No Description
Hansol Medical Co.
0.35mm x 30mm
In Commercial Distribution

  • 08809118710595 ()
  • 18809118710592 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710571

No Description
Hansol Medical Co.
0.35mm x 15mm
In Commercial Distribution

  • 08809118710571 ()
  • 18809118710578 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710557

No Description
Hansol Medical Co.
0.30mm x 120mm
In Commercial Distribution

  • 08809118710557 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710533

No Description
Hansol Medical Co.
0.30mm x 105mm
In Commercial Distribution

  • 08809118710533 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710519

No Description
Hansol Medical Co.
0.30mm x 90mm
In Commercial Distribution

  • 08809118710519 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710496

No Description
Hansol Medical Co.
0.30mm x 75mm
In Commercial Distribution

  • 08809118710496 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710472

No Description
Hansol Medical Co.
0.30mm x 60mm
In Commercial Distribution

  • 08809118710472 ()
  • 18809118710479 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710458

No Description
Hansol Medical Co.
0.30mm x 50mm
In Commercial Distribution

  • 08809118710458 ()
  • 18809118710455 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710434

No Description
Hansol Medical Co.
0.30mm x 40mm
In Commercial Distribution

  • 08809118710434 ()
  • 18809118710431 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710410

No Description
Hansol Medical Co.
0.30mm x 30mm
In Commercial Distribution

  • 08809118710410 ()
  • 18809118710417 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710397

No Description
Hansol Medical Co.
0.30mm x 15mm
In Commercial Distribution

  • 08809118710397 ()
  • 18809118710394 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710373

No Description
Hansol Medical Co.
0.25mm x 120mm
In Commercial Distribution

  • 08809118710373 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710359

No Description
Hansol Medical Co.
0.25mm x 105mm
In Commercial Distribution

  • 08809118710359 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710335

No Description
Hansol Medical Co.
0.25mm x 90mm
In Commercial Distribution

  • 08809118710335 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710311

No Description
Hansol Medical Co.
0.25mm x 75mm
In Commercial Distribution

  • 08809118710311 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710298

No Description
Hansol Medical Co.
0.25mm x 60mm
In Commercial Distribution

  • 08809118710298 ()
  • 18809118710295 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710274

No Description
Hansol Medical Co.
0.25mm x 50mm
In Commercial Distribution

  • 08809118710274 ()
  • 18809118710271 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710250

No Description
Hansol Medical Co.
0.25mm x 40mm
In Commercial Distribution

  • 08809118710250 ()
  • 18809118710257 ()


  • Acupuncture needle, single-use

Hansol Medical Co. - 08809118710236

No Description
Hansol Medical Co.
0.25mm x 30mm
In Commercial Distribution

  • 08809118710236 ()
  • 18809118710233 ()


  • Acupuncture needle, single-use
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