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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

Cannula with Guide - 10840143901607

30cm Cannula with Guide
ATRICURE, INC.
CSK-6131
In Commercial Distribution

  • 10840143901607 ()
  • 30840143901670 ()
  • 50840143900110 ()

  • Length: 30 Centimeter
A001311

  • Cardiac radio-frequency ablation system generator

Chain With Hook - 10840199533289

Charly Chain with Safety Hook 40"
KOROS U.S.A., INC.
7792-90
In Commercial Distribution

  • 00840199533282 ()
  • 10840199533289 ()

  • 9x12mm
7792-90

  • Self-retaining surgical retractor, reusable

Weight with Swivel - 10840199533272

Charly Weight 5 lbs with Swivel
KOROS U.S.A., INC.
7792-80
In Commercial Distribution

  • 00840199533275 ()
  • 10840199533272 ()

  • 9x12mm
7792-80

  • Self-retaining surgical retractor, reusable

Weight with Chain - 10840199533265

Charly Weight 4lbs with Chain
KOROS U.S.A., INC.
7792-50
In Commercial Distribution

  • 00840199533268 ()
  • 10840199533265 ()

  • 9x12mm
7792-50

  • Self-retaining surgical retractor, reusable

Driver with Sleeve - B922F00300180

Driver with Sleeve
INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED
F003.0018
In Commercial Distribution

  • B922F00300180 ()
F003.0018

  • Surgical screwdriver, reusable

FluoroMounter with DAPI - B502BSB01680

FluoroMounter with DAPI is an aqueous mounting media used for counterstaining cells or tissues stained by Immunofluorescence or FISH with DAPI while preserving the fluorescent staining.
BIO SB, INC.
1000 ml
In Commercial Distribution

  • B502BSB01680 ()
BSB 0168

  • DAPI solution IVD

FluoroMounter with DAPI - B502BSB01670

FluoroMounter with DAPI is an aqueous mounting media used for counterstaining cells or tissues stained by Immunofluorescence or FISH with DAPI while preserving the fluorescent staining.
BIO SB, INC.
500 ml
In Commercial Distribution

  • B502BSB01670 ()
BSB 0167

  • DAPI solution IVD

FluoroMounter with DAPI - B502BSB01660

FluoroMounter with DAPI is an aqueous mounting media used for counterstaining cells or tissues stained by Immunofluorescence or FISH with DAPI while preserving the fluorescent staining.
BIO SB, INC.
200 ml
In Commercial Distribution

  • B502BSB01660 ()
BSB 0166

  • DAPI solution IVD

FluoroMounter with DAPI - B502BSB01650

FluoroMounter with DAPI is an aqueous mounting media used for counterstaining cells or tissues stained by Immunofluorescence or FISH with DAPI while preserving the fluorescent staining.
BIO SB, INC.
100 ml
In Commercial Distribution

  • B502BSB01650 ()
BSB 0165

  • DAPI solution IVD

FluoroMounter with DAPI - B502BSB01640

FluoroMounter with DAPI is an aqueous mounting media used for counterstaining cells or tissues stained by Immunofluorescence or FISH with DAPI while preserving the fluorescent staining.
BIO SB, INC.
50 ml
In Commercial Distribution

  • B502BSB01640 ()
BSB 0164

  • DAPI solution IVD

FluoroMounter with DAPI - B502BSB01630

FluoroMounter with DAPI is an aqueous mounting media used for counterstaining cells or tissues stained by Immunofluorescence or FISH with DAPI while preserving the fluorescent staining.
BIO SB, INC.
15 ml
In Commercial Distribution

  • B502BSB01630 ()
BSB 0163

  • DAPI solution IVD

Boomerang with Velcro - B525FI01A0

No Description
Octostop Inc
FI-01A
In Commercial Distribution

  • B525FI01A0 ()


  • X-ray/radiation therapy beam filter, wedge

MRIaudioPREM1001 with MRIview - B66935011

The MRIaudio PREM system with MRIview is an MRI conditional audio and video solution that provides MRI patients with music, visual entertainment, direct communication, and hearing protection.
MRIAUDIO, INC.
3501
In Commercial Distribution

  • B66935011 ()
3501

  • Patient audiovisual communication/entertainment system

MRIaudioPREM1000 with MRIview - B66935001

The MRIaudio PREM system with MRIview is an MRI conditional audio and video solution that provides MRI patients with music, visual entertainment, direct communication, and hearing protection.
MRIAUDIO, INC.
3500
In Commercial Distribution

  • B66935001 ()
3500

  • Patient audiovisual communication/entertainment system

SSU-D with Orifice - 00896241002510

The Nephros SSU-D is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (RO, DI, etc.).
NEPHROS, INC.
70-0243O
Not in Commercial Distribution

  • 10896241002517 ()
  • 00896241002510 ()
  • 20896241002514 ()


  • Microbial water purification filter, non-sterilizable

SSU-D with Orifice - 00896241002503

The Nephros SSU-D is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (RO, DI, etc.).
NEPHROS, INC.
70-0243O
Not in Commercial Distribution

  • 10896241002500 ()
  • 00896241002503 ()


  • Microbial water purification filter, non-sterilizable

Hayrake-Palatal with Spurs - 00889989083545

Hayrake-Palatal with Spurs
ALLESEE AOA-PRO
3000-0073
In Commercial Distribution

  • 00889989083545 ()


  • Orthodontic habit prevention/breaking appliance, bonded

Celebrate with Reese's - 00017276238822

Adhesive Bandages, scary designs, 3/4 IN x 3 IN (19 mm x 76 mm)
Aso LLC
017276238822
In Commercial Distribution

  • 60017276238824 ()
  • 00017276238822 ()


  • Skin-cover adhesive strip, non-antimicrobial

PocketPEP with OxyJET - 10851232007681

A handheld oscillating positive expiratory pressure device for secretion clearance with the ability to deliver supplemental oxygen when used with compressed oxygen.
D R BURTON HEALTHCARE, LLC
1
In Commercial Distribution

  • 30851232007685 ()
  • 10851232007681 ()
537

  • Incentive spirometer

Drill with Handle - 10840199515988

Alif Drill with Handle (Pre-Drill)
KOROS U.S.A., INC.
7332-54
In Commercial Distribution

  • 00840199515981 ()
  • 10840199515988 ()
7332-54

  • Surgical drill guide, reusable

VORTRAN-IPPB with Manomter - 10637320040224

The VORTRAN®-IPPB allows for single-patient use of an airway clearance device. It provides high aerosol output with a large nebulizer reservoir. It is easily set-up and more cost effective than a conventional IPPB machine. It is excellent for patients with fluid retention in the lungs.
VORTRAN MEDICAL TECHNOLOGY 1, INC
IPM-4022
In Commercial Distribution

  • 20637320040221 ()
  • 10637320040224 ()
IPM-4022

  • Ultrasonic nebulizing system

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 - 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 - 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 - 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 - 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 - 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 - 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 - 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

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

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 - 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

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
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