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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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Medline - 30193489181658

SYRINGE,LUER LOCK,STERILE,20ML,PUMPC
MEDLINE INDUSTRIES, INC.
SYR120010PC
In Commercial Distribution

  • 10193489181654 ()
  • 20193489181651 ()
  • 30193489181658 ()
SYR120010PC

  • General-purpose syringe, single-use

Medline - 30193489181641

SYRINGE,LUER LOCK,STERILE,30ML,PUMPC
MEDLINE INDUSTRIES, INC.
SYR130010PC
In Commercial Distribution

  • 10193489181647 ()
  • 20193489181644 ()
  • 30193489181641 ()
SYR130010PC

  • General-purpose syringe, single-use

Medline - 30193489181634

SYRINGE,LUER LOCK,STERILE,60ML,PUMPC
MEDLINE INDUSTRIES, INC.
SYR160010PC
In Commercial Distribution

  • 10193489181630 ()
  • 20193489181637 ()
  • 30193489181634 ()
SYR160010PC

  • General-purpose syringe, single-use

Strong Manufacturers - 00850040791174

Manual stethoscope used to project the sounds associated with the heart, arteries, veins and other internal organs. Single head, yellow, not made with natural rubber latex. Case of 25 each.
Strong Medical Partners LLC
7101
In Commercial Distribution

  • 10850040791171 ()
  • 00850040791174 ()
7101

  • Mechanical external stethoscope

Artemis with ProFuse - 00860009734838

Artemis along with the Needle Guide Attachment is used for image-guided interventional and diagnostic procedures of the prostate gland. It provides 2D and 3D visualization of Ultrasound (US) images and the ability to fuse and register these images with those from other imaging modalities such as Ultrasound, Magnetic Resonance, Computed Tomography, etc. It also provides the ability to display a simulated image of a tracked insertion tool such as a biopsy needle, guidewire or probe on a computer monitor screen that shows images of the target organ and the current and the projected future path of the interventional instrument taking into account patient movement. The software also provides a virtual grid on the live ultrasound for performing systematic sampling of the target organ. Other software features include patient data management, multi-planar reconstruction, segmentation, image measurements, 2D/3D image registration, reporting, and pathology management. Artemis is intended for treatment planning and guidance for clinical, interventional and/or diagnostic procedures. The device is intended to be used in interventional and diagnostic procedures in a clinical setting. Example procedures include, but are not limited to image fusion for diagnostic clinical examinations and procedures, soft tissue biopsies, soft tissue ablations and placement of fiducial markers. Artemis is also intended to be used for patients in active surveillance to keep track of previous procedures information and outcomes.
Eigen Health Services LLC
2.0 HD
In Commercial Distribution

  • 00860009734838 ()


  • Rectal ultrasound navigational image processor

Play With Me - 00850002870572

Play With Me - Pleaser Rechargeable C-Ring - Pink Part Number: BL-31610 Material: ABS / TPE
Blush Novelties
Play With Me - Pleaser Rechargeable C-Ring - Pink
In Commercial Distribution

  • 00850002870572 ()
BL-31610

  • Penile ring

Play With Me - 00850002870565

Play With Me - Pleaser Rechargeable C-Ring - Neon Green Part Number: BL-31622 Material: ABS / TPE
Blush Novelties
Play With Me - Pleaser Rechargeable C-Ring - Neon Green
In Commercial Distribution

  • 00850002870565 ()
BL-31622

  • Penile ring

Play With Me - 00850002870480

Play With Me - Arouser Vibrating C-Ring - Green Part Number: BL-30622 Material Type: TPE, ABS
Blush Novelties
Play With Me - Arouser Vibrating C-Ring - Green
In Commercial Distribution

  • 00850002870480 ()
BL-30622

  • Penile ring

Play With Me - 00850002870473

Play With Me - Arouser Vibrating C-Ring - Pink Part Number: BL-30610 Material Type: TPE, ABS
Blush Novelties
Play With Me - Arouser Vibrating C-Ring - Pink
In Commercial Distribution

  • 00850002870473 ()
BL-30610

  • Penile ring

Play With Me - 00850002870466

Play With Me - One Night Stand Vibrating C-Ring - Purple Part Number: BL-30811 Material Type: TPE, ABS
Blush Novelties
Play With Me - One Night Stand Vibrating C-Ring - Purple
In Commercial Distribution

  • 00850002870466 ()
BL-30811

  • Penile ring

Play With Me - 00850002870459

Play With Me - One Night Stand Vibrating C-Ring - Blue Part Number: BL-30812 Material Type: TPE, ABS
Blush Novelties
Play With Me - One Night Stand Vibrating C-Ring - Blue
In Commercial Distribution

  • 00850002870459 ()
BL-30812

  • Penile ring

Play With Me - 00850002870435

Play with Me - Delight Vibrating C-Ring - Blue Part Number: BL-74302 Material Type: TPE, ABS
Blush Novelties
Play with Me - Delight Vibrating C-Ring - Blue
In Commercial Distribution

  • 00850002870435 ()
BL-74302

  • Penile ring

Play With Me - 00850002870428

Play with Me - Delight Vibrating C-Ring - Pink Part Number: BL-74300 Material Type: TPE, ABS
Blush Novelties
Play with Me - Delight Vibrating C-Ring - Pink
In Commercial Distribution

  • 00850002870428 ()
BL-74300

  • Penile ring

Play With Me - 00850002870329

Play with Me - Teaser Vibrating C-Ring - Pink Part Number: BL-74100 Material Type: TPE, ABS
Blush Novelties
Play with Me - Teaser Vibrating C-Ring - Pink
In Commercial Distribution

  • 00850002870329 ()
BL-74100

  • Penile ring

Play With Me - 00850002870282

Play With Me - Pleaser Rechargeable C-Ring - Blue Part Number: BL-31912 Material Type: TPE, ABS
Blush Novelties
Play With Me - Pleaser Rechargeable C-Ring - Blue
In Commercial Distribution

  • 00850002870282 ()
BL-31912

  • Penile ring

Triton with Evox - 00627825004534

No Description
Laborie Medical Technologies Canada ULC
PRO839
In Commercial Distribution

  • 00627825004534 ()


  • Urodynamic measurement system

ActiSplint with Sensi-Wrap - 00616784353333

ActiSplint with Sensi-Wrap 2"x5yds, Red/Charcoal Gray Rolled Splint, Black Self-Adherent Bandage, 36" ActiSplint, 2"x5 Sensi Wrap; Combo Packs
Dynarex Corporation
3533
In Commercial Distribution

  • 00616784353319 ()
  • 00616784353333 ()


  • Arm splint system, self-moulding

STARBoard with Extension - 09421902825873

Arm Support for Interventional Radiology
ADEPT MEDICAL LIMITED
AM0180
In Commercial Distribution

  • 09421902825873 ()
AM0180

  • Radiological arm/leg positioner

Micromotor with Cord - 04560224995149

No Description
NAKANISHI INC.
Micromotor with Cord
Not in Commercial Distribution

  • 04560224995149 ()


  • Dental surgical power tool motor, electric

Play With Me - 00850002870442

Play With Me - Pleaser Rechargeable C-Ring - Purple Part Number: BL-31911 Material Type: TPE, ABS
Blush Novelties
Play With Me - Pleaser Rechargeable C-Ring - Purple
In Commercial Distribution

  • 00850002870442 ()
BL-31911

  • Penile ring

Play With Me - 00850002870411

Play with Me - Bull Vibrating C-Ring - Purple Part Number: BL-74201 Material Type: TPE, ABS
Blush Novelties
Play with Me - Bull Vibrating C-Ring - Purple
In Commercial Distribution

  • 00850002870411 ()
BL-74201

  • Penile ring

Play With Me - 00850002870312

Play with Me - Teaser Vibrating C-Ring - Green Part Number: BL-74122 Material Type: TPE, ABS
Blush Novelties
Play with Me - Teaser Vibrating C-Ring - Green
In Commercial Distribution

  • 00850002870312 ()
BL-74122

  • Penile ring

Play With Me - 00850002870305

Play with Me - Bull Vibrating C-Ring - Blue Part Number: BL-74202 Material Type: TPE, ABS
Blush Novelties
Play with Me - Bull Vibrating C-Ring - Blue
In Commercial Distribution

  • 00850002870305 ()
BL-74202

  • Penile ring

Play With Me - 00850002870237

Play With Me - Couples Play - Vibrating Cock Ring - Purple Part Number: BL-77901 Material Type: TPE
Blush Novelties
Couples Play - Vibrating Cock Ring - Purple
In Commercial Distribution

  • 00850002870237 ()
BL-77901

  • Penile ring

Probe with roller - 14897076722843

No Description
TENS PLUS INDUSTRIAL COMPANY
BY2347
In Commercial Distribution

  • 14897076722843 ()


  • External manual massager, clinical

TOGGLELOC WITH ZIPLOOP - 00880304478923

No Description
Biomet Sports Medicine, LLC
909874
In Commercial Distribution

  • 00880304478923 ()

  • 4.5 MM
909874

  • Ligament bone anchor

TOGGLELOC WITH ZIPLOOP - 00880304472709

No Description
Biomet Sports Medicine, LLC
909849
In Commercial Distribution

  • 00880304472709 ()
909849

  • Ligament reconstruction instrument set, reusable

ToggleLoc with Ziploop - 00880304470361

No Description
Biomet Orthopedics, LLC
909854
In Commercial Distribution

  • 00880304470361 ()

  • 4.5 MM
909854

  • Ligament reconstruction instrument set, reusable

ToggleLoc with Ziploop - 00880304469471

No Description
Biomet Orthopedics, LLC
904753
In Commercial Distribution

  • 00880304469471 ()

  • 4.5 MM
904753

  • Tendon/ligament bone anchor, non-bioabsorbable

ToggleLoc With Ziploop - 00880304453364

No Description
Biomet Orthopedics, LLC
904755
In Commercial Distribution

  • 00880304453364 ()
904755

  • Tendon/ligament bone anchor, non-bioabsorbable

TOGGLELOC WITH ZIPLOOP - 00880304676947

No Description
Biomet Sports Medicine, LLC
110017308
In Commercial Distribution

  • 00880304676947 ()

  • 2.9 MM
110017308

  • Tendon/ligament bone anchor, non-bioabsorbable

TOGGLELOC WITH ZIPLOOP - 00880304676930

No Description
Biomet Orthopedics, LLC
110010384
In Commercial Distribution

  • 00880304676930 ()

  • 2.9 MM
110010384

  • Tendon/ligament bone anchor, non-bioabsorbable

ToggleLoc With Ziploop - 00880304464858

No Description
Biomet Orthopedics, LLC
904754
In Commercial Distribution

  • 00880304464858 ()
904754

  • Tendon/ligament bone anchor, non-bioabsorbable

TOGGLELOC WITH ZIPLOOP - 00880304464773

No Description
Biomet Sports Medicine, LLC
909848
In Commercial Distribution

  • 00880304464773 ()
909848

  • Ligament reconstruction instrument set, reusable

ToggleLoc With Ziploop - 00880304464223

No Description
Biomet Orthopedics, LLC
904756
In Commercial Distribution

  • 00880304464223 ()
904756

  • Tendon/ligament bone anchor, non-bioabsorbable

Immobilization Kit, with - 05707480038619

Ambu® Military Perfit ACE™ and Ambu® Military Head Wedge™, Adult
Ambu A/S
000281153
In Commercial Distribution

  • 05707480038626 ()
  • 05707480038619 ()

  • Adult
000281153

  • Cervical spine collar, single-use

Immobilization Kit, with - 05707480037315

Ambu® Perfit ACE™ and Ambu® Head Wedge™, Adult
Ambu A/S
000281152
In Commercial Distribution

  • 05707480037308 ()
  • 05707480037315 ()

  • Adult
000281152

  • Cervical spine collar, single-use

Immobilization Kit, with - 05707480024674

Ambu® Mini Perfit ACE™ and Ambu® Head Wedge™, Small Pediatric and Pediatric
Ambu A/S
000281161
In Commercial Distribution

  • 05707480006557 ()
  • 05707480024674 ()

  • Mini
000281161

  • Cervical spine collar, single-use

Play With Me - 00853858007956

Play With Me - Double Play - Dual Vibrating Cock Ring - Purple Part Number:BL-77101 Material Type: TPE-ABS
Blush Novelties
Play With Me - Double Play - Dual Vibrating Cock Ring - Purple
In Commercial Distribution

  • 00853858007956 ()
BL-77101

  • Penile ring

Play With Me - 00853858007628

Play With Me - King of the Ring Part Number:BL-93652 Material Type: TPE
Blush Novelties
Play With Me - King of the Ring
In Commercial Distribution

  • 00853858007628 ()
BL-93652

  • Penile ring

Play With Me - 00853858007611

Play With Me - Stretch C-Ring - 50 pieces Part Number: BC-009 Material Type: TPE
Blush Novelties
Play With Me - Stretch C-Ring - 50 pieces
In Commercial Distribution

  • 00853858007611 ()
BC-009

  • Penile ring

PLAY WITH ME - 00853858007598

Play With Me - Lick It - Vibrating Double Strap Cock Ring - Purple Part Number: BL-61911 Material Type: TPE
Blush Novelties
Play With Me - Lick It - Vibrating Double Strap Cock Ring - Purple
In Commercial Distribution

  • 00853858007598 ()
BL-61911

  • Penile ring

Immobilization Kit, with - 05707480024667

Ambu® Perfit ACE™ and Ambu® Head Wedge™, Adult
Ambu A/S
000281151
In Commercial Distribution

  • 05707480006540 ()
  • 05707480024667 ()

  • Adult
000281151

  • Cervical spine collar, single-use

Rectosigmoidoscope with Obturator - 05704916001360

Rectosigmoidoscope with obturator, compatible with Storz Light Source for 20R3 / 9052
Bk Medical ApS
UA0673
In Commercial Distribution

  • 05704916001360 ()


  • Rigid endoscope obturator

Rectosigmoidoscope with Obturator - 05704916001353

Rectosigmoidoscope with obturator, compatible with Welch Allyn Light Source for 20R3 / 9052
Bk Medical ApS
UA0672
In Commercial Distribution

  • 05704916001353 ()


  • Rigid endoscope obturator

COVERLET WITH ZIPPER - 00850520008211

Silver Coverlet with Zipper
KREG MEDICAL INC.
ASM100118
In Commercial Distribution

  • 00850520008211 ()


  • Waterproof bed mattress cover, reusable
  • Antimicrobial bed mattress cover

COVERLET WITH ZIPPER - 00850520008204

Deep Purple Coverlet with Zipper
KREG MEDICAL INC.
ASM100117
In Commercial Distribution

  • 00850520008204 ()


  • Waterproof bed mattress cover, reusable
  • Antimicrobial bed mattress cover

Flex-MI with Electrodes - 00859718007289

Power muscle stimulator with Electrodes
Emsi
FLEMC0001
In Commercial Distribution

  • 00859718007289 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
  • Transcutaneous electrical stimulation electrode, single-use

Endo-Chisel, with handle - 04250337119630

Bone Ablating Instruments (Curettes, Dissectors and Chisels) are hand-held manual surgical instruments, used to dissect or scrape/chisel tissue from a bony or soft tissue structure during minimally invasive endoscopic spinal surgery. It is typically a long, rigid instrument constructed of medical-grade stainless steel whose distal end has one or more sharp edges in order to fulfill the intended function described above. This is a reusable device.
Joimax GmbH
TEC273715
In Commercial Distribution

  • 04250337119630 ()


  • Orthopaedic chisel

ViVIX-S with VXvue - 08809394330081

No Description
VIEWORKS CO., LTD.
FXRD-1417SB
Not in Commercial Distribution

  • 08809394330081 ()


  • Indirect flat panel x-ray detector
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