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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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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

ViVIX-S with VXvue - 08809394330081

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

  • 08809394330081 ()


  • Indirect flat panel x-ray detector

ViVIX-S with VXvue - 08809394330005

No Description
VIEWORKS CO., LTD.
FXRD-1717SA
Not in Commercial Distribution

  • 08809394330005 ()


  • Indirect flat panel x-ray detector

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

Facebow with QLT - D040343441

A facebow is a device intended for use in a dental diagnostic procedure to record the relative position of the mandible to the temporomandibular joints (TMJs) and/or to record the spatial relationship between the maxilla and mandible. This is a reusable device.
WHIP-MIX CORPORATION
9155Q
In Commercial Distribution

  • D040343441 ()
9155Q

  • Facebow

ASPIJECT WITH O-RING - 00303620000017

Dental cartridge syringe
SEPTODONT, INC
01N2030
In Commercial Distribution

  • 00303620000017 ()

  • Total Volume: 1.8 Milliliter
01N2030

  • Syringe-loaded medication/vaccine injector, manual, professional

ViVIX-S with VXvue - 08809394330050

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

  • 08809394330050 ()


  • Indirect flat panel x-ray detector

T-Handle with Ratchet - 04057217005867

No Description
Z-Medical GmbH + Co. KG
A16 374
In Commercial Distribution

  • 04057217005867 ()


  • Surgical instrument handle, non-torque-limiting

STARBoard with Extension - 09421902825873

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

  • 09421902825873 ()
AM0180

  • Radiological arm/leg positioner

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

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 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

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

Awl With Stop - B806RO0016ASZZ0

Awl With Stop
Spineup, Inc.
RO0016ASZZ
In Commercial Distribution

  • B806RO0016ASZZ0 ()
RO0016ASZZ

  • Bone awl, reusable

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

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

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

SPECTRUM WITH MDL - 00085412091570

The Spectrum infusion pump consists of electronic circuitry and mechanisms in a plastic enclosure. The operation is software controlled, with linear peristaltic pumping design. The Spectrum is designed for the application of standard gravity infusion sets as indicated by the Spectrums labeling.
BAXTER INTERNATIONAL INC.
35700BAX
In Commercial Distribution

  • 00085412091570 ()
35700BAX

  • Bedside infusion pump, single-channel

Hayrake-Palatal with Spurs - 00889989083545

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

  • 00889989083545 ()


  • Orthodontic habit prevention/breaking appliance, bonded

Tray With Brackets - 00192896121072

Tray With Brackets Stainless Steel
SONTEC INSTRUMENTS, INC.
18-2001
In Commercial Distribution

  • 00192896121072 ()

  • Height: 14 Millimeter
  • Length: 400 Millimeter
  • Width: 250 Millimeter
18-2001

  • Instrument tray, reusable

Probe With Eye - 00192896116252

Probe With Eye Stainless
SONTEC INSTRUMENTS, INC.
197-662
In Commercial Distribution

  • 00192896116252 ()

  • Length: 5.5 Inch
197-662

  • Gastro-urological director

Probe With Eye - 00192896110076

Probe With Eye Stainless Steel
SONTEC INSTRUMENTS, INC.
197-666
In Commercial Distribution

  • 00192896110076 ()

  • Length: 9 Inch


  • Gastro-urological director

Osteotome With Guide - 00192896108929

Osteotome With Guide Straight 3 Millimeters
SONTEC INSTRUMENTS, INC.
475-785G2
In Commercial Distribution

  • 00192896108929 ()

  • Length: 7.25 Inch


  • Plastic surgery osteotome

INSERT WITH MAT - 00192896019430

INSERT WITH MAT
SONTEC INSTRUMENTS, INC.
1103-7171
In Commercial Distribution

  • 00192896019430 ()

  • Length: 11 Inch
  • Height: 1.5 Inch
  • Width: 7 Inch
1103-7171

  • Instrument tray, reusable

Driver with Sleeve - B922F00300180

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

  • B922F00300180 ()
F003.0018

  • Surgical screwdriver, 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

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

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

ConnectWeb with PACSCore - B295FULLPACS30

ConnectWeb viewer front-end with PACSCore back-end archive
Radius
3
In Commercial Distribution

  • B295FULLPACS30 ()


  • Radiological PACS software

Faceshield with filter - B00230000

disposable CPR faceshield with one way valve and filter
B.L.S. Systems Limited
3000
In Commercial Distribution

  • B00230007 ()
  • B00230000 ()
3000

  • Cardiopulmonary resuscitation mask, single-use

Boomerang with Velcro - B525FI01A0

No Description
Octostop Inc
FI-01A
In Commercial Distribution

  • B525FI01A0 ()


  • X-ray/radiation therapy beam filter, wedge

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

BG545 with EPI28A - B101100743XI0

No Description
CME AMERICA LLC
100-743XI
Not in Commercial Distribution

  • B101100743XI0 ()


  • Bedside infusion pump, single-channel

Syringe with needle - 06958697602875

A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
LS - 1ml 23G X 1"
In Commercial Distribution

  • 16958697602872 ()
  • 06958697602875 ()
  • 26958697602879 ()
T1ML2325E

  • Metered-delivery hypodermic syringe

Syringe with needle - 06958697602813

A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
LL - 3ml 25G X 1"
In Commercial Distribution

  • 16958697602810 ()
  • 06958697602813 ()
  • 26958697602817 ()
SLL3N2525

  • Metered-delivery hypodermic syringe

Syringe with needle - 06958697602806

A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
LL - 3ml 23G X 1"
In Commercial Distribution

  • 16958697602803 ()
  • 06958697602806 ()
  • 26958697602800 ()
SLL3N2325

  • Metered-delivery hypodermic syringe

Syringe with needle - 06958697602752

A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
LS - 1ml 23G X 1"
In Commercial Distribution

  • 16958697602759 ()
  • 06958697602752 ()
  • 26958697602756 ()
T1ML2325E

  • Metered-delivery hypodermic syringe

Syringe with needle - 06958697602745

A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
LL - 3ml 23G X 1"
In Commercial Distribution

  • 16958697602742 ()
  • 06958697602745 ()
  • 26958697602749 ()
T3ML2325E

  • Metered-delivery hypodermic syringe

Syringe with needle - 06958697602684

A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
LS-1ml 23G X 1"
In Commercial Distribution

  • 16958697602681 ()
  • 06958697602684 ()
  • 26958697602688 ()
T1ML2325E

  • Metered-delivery hypodermic syringe

Syringe with needle - 06958697602622

A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
LS - 1ml 25G X 1"
In Commercial Distribution

  • 16958697602629 ()
  • 06958697602622 ()
  • 26958697602626 ()
SLS1N2525

  • Metered-delivery hypodermic syringe

Syringe with needle - 06958697602608

A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
LL - 1ml 25G X 1"
In Commercial Distribution

  • 16958697602605 ()
  • 06958697602608 ()
  • 26958697602602 ()
SLL1N2525

  • Metered-delivery hypodermic syringe

Syringe with needle - 06958697602592

A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
LS - 1ml 25G X 1"
In Commercial Distribution

  • 16958697602599 ()
  • 06958697602592 ()
  • 26958697602596 ()
SLS1N2525

  • Metered-delivery hypodermic syringe
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