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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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PEEK SPACER WITH X-RAY MARKERS - 00888480456315

No Description
BIOMET SPINE LLC
14-531357
In Commercial Distribution

  • 00888480456315 ()

  • C-THRU LORDOTIC 16X14X7MM
14-531357

  • Polymeric spinal fusion cage, sterile

PEEK SPACER WITH X-RAY MARKERS - 00888480456308

No Description
BIOMET SPINE LLC
14-531356
In Commercial Distribution

  • 00888480456308 ()

  • C-THRU LORDOTIC 16X14X6MM
14-531356

  • Polymeric spinal fusion cage, sterile

PEEK SPACER WITH X-RAY MARKERS - 00888480456292

No Description
BIOMET SPINE LLC
14-531355
In Commercial Distribution

  • 00888480456292 ()

  • C-THRU LORDOTIC 16X14X5MM
14-531355

  • Polymeric spinal fusion cage, sterile

PEEK SPACER WITH X-RAY MARKERS - 00888480456285

No Description
BIOMET SPINE LLC
14-531352
In Commercial Distribution

  • 00888480456285 ()

  • C-THRU LORDOTIC 12X12X12MM
14-531352

  • Polymeric spinal fusion cage, sterile

PEEK SPACER WITH X-RAY MARKERS - 00888480456278

No Description
BIOMET SPINE LLC
14-531351
In Commercial Distribution

  • 00888480456278 ()

  • C-THRU LORDOTIC 12X12X11MM
14-531351

  • Polymeric spinal fusion cage, sterile

PEEK SPACER WITH X-RAY MARKERS - 00888480456261

No Description
BIOMET SPINE LLC
14-531350
In Commercial Distribution

  • 00888480456261 ()

  • C-THRU LORDOTIC 12X12X10MM
14-531350

  • Polymeric spinal fusion cage, sterile

PEEK SPACER WITH X-RAY MARKERS - 00888480456254

No Description
BIOMET SPINE LLC
14-531349
In Commercial Distribution

  • 00888480456254 ()

  • C-THRU LORDOTIC 12X12X9MM
14-531349

  • Polymeric spinal fusion cage, sterile

PEEK SPACER WITH X-RAY MARKERS - 00888480456247

No Description
BIOMET SPINE LLC
14-531348
In Commercial Distribution

  • 00888480456247 ()

  • C-THRU LORDOTIC 12X12X8MM
14-531348

  • Polymeric spinal fusion cage, sterile

PEEK SPACER WITH X-RAY MARKERS - 00888480456230

No Description
BIOMET SPINE LLC
14-531347
In Commercial Distribution

  • 00888480456230 ()

  • C-THRU LORDOTIC 12X12X7MM
14-531347

  • Polymeric spinal fusion cage, sterile

PEEK SPACER WITH X-RAY MARKERS - 00888480456223

No Description
BIOMET SPINE LLC
14-531346
In Commercial Distribution

  • 00888480456223 ()

  • C-THRU LORDOTIC 12X12X6MM
14-531346

  • Polymeric spinal fusion cage, sterile

Single Leader Catheter with Luer - B1656039032610124134

15ga single leader catheter with female luer and button, 1/pack
Liberty Medical , Inc.
6039
In Commercial Distribution

  • B1656039032610124134 ()


  • General-purpose brachytherapy system applicator, manual

Single Leader Catheter with Luer - B16560390326093024113

15ga single leader catheter with female luer and button, 1/pack
Liberty Medical , Inc.
6039
In Commercial Distribution

  • B16560390326093024113 ()


  • General-purpose brachytherapy system applicator, manual

Single Leader Catheter with Button - B16556530326033124037

15ga, 30 cm single leader catheters with colored button, 5/pack
Liberty Medical , Inc.
5653
In Commercial Distribution

  • B16556530326033124037 ()


  • General-purpose brachytherapy system applicator, manual

Single Leader Catheter with Button - B16556450326083124107

15ga single leader catheter with colored button, 1/pack
Liberty Medical , Inc.
5641
In Commercial Distribution

  • B16556450326083124107 ()


  • General-purpose brachytherapy system applicator, manual

Single Leader Catheter with Button - B16556410326093024120

15ga single leader catheter with colored button, 5/pack
Liberty Medical , Inc.
5641
In Commercial Distribution

  • B16556410326093024120 ()


  • General-purpose brachytherapy system applicator, manual

Single Leader Catheter with Button - B16556410326033124042

15ga single leader catheter with colored button, 5/pack
Liberty Medical , Inc.
5641
In Commercial Distribution

  • B16556410326033124042 ()


  • General-purpose brachytherapy system applicator, manual

CAPILLAROSCOPE WITH PROFESSIONAL SW (500x) - B1623191

CAPILLAROSCOPE WITH PROFESSIONAL SW (500x)
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-319
Not in Commercial Distribution

  • B1623191 ()
FEDMEDMICFIT6SWC_US

  • Otoscope, direct

CAPILLAROSCOPE WITH PROFESSIONAL SW (5X-200x) - B1623171

CAPILLAROSCOPE WITH PROFESSIONAL SW (5X-200x)
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-317
Not in Commercial Distribution

  • B1623171 ()
FEDMEDMICFISTDSWC_US

  • Otoscope, direct

DEMATOSCOPE WITH PROFESSIONAL SW (10X-90x) - B1623161

DEMATOSCOPE WITH PROFESSIONAL SW (10X-90x)
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-316
Not in Commercial Distribution

  • B1623161 ()
FEDMEDMICFIUVWPSWD_US

  • Otoscope, direct

DEMATOSCOPE WITH PROFESSIONAL SW (5X-200x) - B1623141

DEMATOSCOPE WITH PROFESSIONAL SW (5X-200x)
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-314
Not in Commercial Distribution

  • B1623141 ()
FEDMEDMICFIPSWD_US

  • Otoscope, direct

BELLOW WITH VENTIL AND CONNECTION - B0990411020100

BELLOW BLUE WITH VENTIL AND CONNECTION M8
SONTEC INSTRUMENTS, INC.
04-11020-10
Not in Commercial Distribution

  • B0990411020100 ()


  • ENT powder applicator

Oral + Nasal Cannula with Filter - B14085990

Tubing used to detect airflow in sleep studies.
Braebon Medical Corporation
8599
In Commercial Distribution

  • B14085990 ()
8599

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

BRAEBON Q-RIP Interface with SUM - B140057120

Component of the Q-RIP™ Respiratory Effort System™ which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a data acquisition system. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier.
Braebon Medical Corporation
0571.2
In Commercial Distribution

  • B140057120 ()
0571.2

  • Pneumograph

ScopeSafe Laser Fiber with SoftTip - B145116130

272 micrometer ScopeSafe™ Laser Fiber with SoftTip™
OPTICAL INTEGRITY INC
11613
In Commercial Distribution

  • B145116130 ()
  • B145116135 ()
  • B145116131 ()
  • B145116831 ()
  • B145116150 ()
  • B145116171 ()

  • Outer Diameter: 272 Micrometer
SU-200-ST

  • General/multiple surgical laser system beam guide, reusable

ScopeSafe Laser Fiber with SoftTip - B145116070

200 micrometer ScopeSafe™ Laser Fiber with SoftTip™
OPTICAL INTEGRITY INC
11607
In Commercial Distribution

  • B145116070 ()
  • B145116111 ()

  • Outer Diameter: 375 Micrometer
SU-200-TRUE-ST

  • General/multiple surgical laser system beam guide, reusable

T-HANDLE WITH A/O ADAPTOR - 00888480233749

No Description
Biomet Orthopedics, LLC
24345
In Commercial Distribution

  • 00888480233749 ()
24345

  • Surgical instrument handle, non-torque-limiting

PLEGIOX Heat Exchanger with Cardioplegia - 04037691180038

The PLEGIOX cardioplegia heat exchanger is used for adjusting the temperature of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The PLEGIOX contains heat exchanger fibers through which the cooling or heating fluid is pumped. The fluid to be temperature controlled flows around the outside of these fibers. Deairing is ensured by a bubble trap with a filter integrated in the upper part of the PLEGIOX. An integrated bypass stopcock enables hot-shot to be performed.
Maquet Cardiopulmonary AG
CHX 30, Non-coated, Sterile
Not in Commercial Distribution

  • 04037691180038 ()
  • 04058863052267 ()

  • Total Volume: 46.885 Liter
  • Weight: 0.35 Kilogram
70103.2522

  • Cardiopulmonary bypass system heat exchanger, reusable

Electrode Cable with Straight Plug - 04032767084715

No Description
Otto Bock Healthcare Products GmbH
13E48=G800
Not in Commercial Distribution

  • 04032767084715 ()


  • Myoelectric hand prosthesis

Electrode Cable with Straight Plug - 04032767084692

No Description
Otto Bock Healthcare Products GmbH
13E48=G300
Not in Commercial Distribution

  • 04032767084692 ()


  • Myoelectric hand prosthesis

Aquatec R with blue cover-so - 04028698125542

Aquatec R with blue cover-so
INVACARE CORPORATION
1574456
In Commercial Distribution

  • 04028698125542 ()
1574456

  • Basic toilet seat

Aquatec R with white cover-so - 04028698125535

Aquatec R with white cover-so
INVACARE CORPORATION
1574455
In Commercial Distribution

  • 04028698125535 ()
1574455

  • Basic toilet seat

Aquatec R with blue cover - 04028698125344

Aquatec R with blue cover
INVACARE CORPORATION
1573972
In Commercial Distribution

  • 04028698125344 ()
1573972

  • Basic toilet seat

Aquatec R with white cover - 04028698125313

Aquatec R with white cover
INVACARE CORPORATION
1573878
In Commercial Distribution

  • 04028698125313 ()
1573878

  • Basic toilet seat

Aquatec R with white cover - 04028698125306

Aquatec R with white cover
INVACARE CORPORATION
1573877
In Commercial Distribution

  • 04028698125306 ()
1573877

  • Basic toilet seat

Aquatec XL with white cover - 04028698125238

Aquatec XL with white cover
INVACARE CORPORATION
1573862
In Commercial Distribution

  • 04028698125238 ()
1573862

  • Basic toilet seat

Aquatec F with white cover - 04028698125177

Aquatec F with white cover
INVACARE CORPORATION
1573683
Not in Commercial Distribution

  • 04028698125177 ()
1573683

  • Basic toilet seat

Micro tube 0.5ml with cap - 04038917083782

No Description
Sarstedt Aktiengesellschaft & Co.KG
72.730
Not in Commercial Distribution

  • 04038917165990 ()
  • 04038917083782 ()
72.730

  • Assay container IVD, single-use

Micro tube 2ml with cap - 04038917083461

No Description
Sarstedt Aktiengesellschaft & Co.KG
72.694
In Commercial Distribution

  • 04038917165686 ()
  • 04038917083461 ()
72.694

  • Assay container IVD, single-use

Micro tube 2ml with cap - 04038917083454

No Description
Sarstedt Aktiengesellschaft & Co.KG
72.693
In Commercial Distribution

  • 04038917165679 ()
  • 04038917083454 ()
72.693

  • Assay container IVD, single-use

Micro tube 1.5ml with cap - 04038917083447

No Description
Sarstedt Aktiengesellschaft & Co.KG
72.692
In Commercial Distribution

  • 04038917165662 ()
  • 04038917083447 ()
72.692

  • Assay container IVD, single-use

BB Container Tray with Cover - 10840199502407

BB Container Tray 21.25x10x2.75
KOROS U.S.A., INC.
7320-95
In Commercial Distribution

  • 00840199502400 ()
  • 10840199502407 ()
7320-95

  • Self-retaining surgical retractor, reusable

CALLCORD,8FT,3701,WITH INTERLOCK - 00840828127349

CALLCORD,8FT,3701,WITH INTERLOCK
CURBELL MEDICAL PRODUCTS, INC.
CC96-979
In Commercial Distribution

  • 00840828127349 ()
5873

  • Fixed call button

Micro tube 0.5ml with cap - 04038917994484

No Description
Sarstedt Aktiengesellschaft & Co.KG
72.730.309
In Commercial Distribution

  • 04038917994507 ()
  • 04038917994484 ()


  • Assay container IVD, single-use

Micro tube 0.5ml with cap - 04038917994316

No Description
Sarstedt Aktiengesellschaft & Co.KG
72.730.307
In Commercial Distribution

  • 04038917994330 ()
  • 04038917994316 ()


  • Assay container IVD, single-use

Micro tube 0.5ml with cap - 04038917994026

No Description
Sarstedt Aktiengesellschaft & Co.KG
72.730.300
In Commercial Distribution

  • 04038917994040 ()
  • 04038917994026 ()


  • Assay container IVD, single-use

Micro tube 1.5ml with cap - 04038917431149

No Description
Sarstedt Aktiengesellschaft & Co.KG
72.703.207
In Commercial Distribution

  • 04038917431156 ()
  • 04038917431149 ()
72.703.207

  • Assay container IVD, single-use

Urine cup with transfer device - 04038917236805

No Description
Sarstedt Aktiengesellschaft & Co.KG
75.562.400
In Commercial Distribution

  • 04038917236812 ()
  • 04038917236805 ()
75.562.400

  • Non-evacuated urine specimen container IVD, no additive

Micro tube 0.5ml with cap - 04038917390804

No Description
Sarstedt Aktiengesellschaft & Co.KG
72.730.407
In Commercial Distribution

  • 04038917390811 ()
  • 04038917390804 ()
72.730.407

  • Assay container IVD, single-use

Micro tube 2.0ml with cap - 04038917390774

No Description
Sarstedt Aktiengesellschaft & Co.KG
72.694.407
In Commercial Distribution

  • 04038917390781 ()
  • 04038917390774 ()
72.694.407

  • Assay container IVD, single-use

Micro tube 2ml with cap - 04038917380744

No Description
Sarstedt Aktiengesellschaft & Co.KG
72.694.065
In Commercial Distribution

  • 04038917380751 ()
  • 04038917380744 ()
72.694.065

  • Assay container IVD, single-use
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