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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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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

NEEDLE, AIR ASPIRATOR 16 GA W/BLUE CAP - B066201005NS1

A sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device.
NOVOSCI CORP.
201005NS
In Commercial Distribution

  • B066201005NS6 ()
  • B066201005NS1 ()
  • B066201005NS5 ()
  • B066201005NS4 ()
  • B066201005NS3 ()
  • B066201005NS2 ()
  • B066201005NS0 ()
201005NS

  • Body aspiration needle, single-use

BLUE CAP, NON-VENTED FEMALE - B066000325011NS1

A small, noninvasive, closed-ended Luer attachment intended to be attached to a luminal device (e.g., catheter, intravenous administration or pressure-monitoring tubing, syringe) with a Luer connection to close the device lumen, typically to prevent fluid path contamination and/or spillage; it is not intended to disinfect/maintain disinfection. It is typically made of synthetic polymers and may incorporate a strap; it does not incorporate a filter or valve. This is a single-use device.
NOVOSCI CORP.
000325-011NS
In Commercial Distribution

  • B066000325011NS6 ()
  • B066000325011NS1 ()
  • B066000325011NS5 ()
  • B066000325011NS4 ()
  • B066000325011NS3 ()
  • B066000325011NS2 ()
  • B066000325011NS0 ()
000325-011NS

  • Luer-formatted protective cap

MAX-100 - B641MAX1000

Sterile syringe delivery device used to deliver (inject) Volumex (Iodinated I-131Allbumin injection) for use in determinations of total blood and plasma volumes.
DAXOR CORPORATION
MAX-100 Syringe
In Commercial Distribution

  • B641MAX1004 ()
  • B641MAX1002 ()
  • B641MAX1000 ()
  • B641MAX1003 ()
  • B641MAX1001 ()
  • B641MAX1005 ()


  • Metered-delivery hypodermic syringe

BIOFLUX - B635BIOFLUX100

No Description
BIOTRICITY INC
1.0
In Commercial Distribution

  • B635BIOFLUX101 ()
  • B635BIOFLUX100 ()
  • B635BIOFLUX105 ()
  • B635BIOFLUX104 ()
  • B635BIOFLUX103 ()
  • B635BIOFLUX102 ()


  • Electrocardiography telemetric monitoring system transmitter

Movement and Compressions System (MAC) - B547RF14300

MAC Charger
Recovery Force, LLC
B
In Commercial Distribution

  • B547RF14300 ()
  • B547RF1440237 ()
  • B547RF1440207 ()
  • B547RF1440217 ()
  • B547RF1440227 ()
  • B547RF143009 ()

  • Length: 203 Millimeter
RF1430

  • Intermittent venous compression system

Vitale - B492202670

Vitale Silicone Super-Absorbent Dressings, 6" x 7", 10/box, 10 boxes/case, 2 cases/overpack
CELLERA LLC
20267
Not in Commercial Distribution

  • B492202673 ()
  • B492202671 ()
  • B492202670 ()
  • B492202672 ()
  • B49220673 ()
20267

  • Exudate-absorbent dressing, non-gel, non-antimicrobial

Molded Products, Inc. - B144MPC1500

Male to Male Luer Adapter
MOLDED PRODUCTS, INC.
MPC-150
In Commercial Distribution

  • B144MPC1503 ()
  • B144MPC1502 ()
  • B144MPC1501 ()
  • B144MPC1500 ()
  • B144MPC1504 ()
MPC-150

  • Haemodialysis blood tubing set, single-use

Molded Products, Inc. - B144MPC125Y0

Luer Lock Cap
MOLDED PRODUCTS, INC.
MPC-125Y
In Commercial Distribution

  • B144MPC125Y3 ()
  • B144MPC125Y2 ()
  • B144MPC125Y1 ()
  • B144MPC125Y0 ()
  • B144MPC125Y4 ()
MPC-125Y

  • Luer-formatted disinfection cap

Molded Products, Inc. - B144MPC125R0

Luer Lock Cap
MOLDED PRODUCTS, INC.
MPC-125R
In Commercial Distribution

  • B144MPC125R3 ()
  • B144MPC125R2 ()
  • B144MPC125R1 ()
  • B144MPC125R0 ()
  • B144MPC125R4 ()
MPC-125R

  • Luer-formatted disinfection cap

Molded Products, Inc. - B144MPC125B0

Luer Lock Cap
MOLDED PRODUCTS, INC.
MPC-125B
In Commercial Distribution

  • B144MPC125B3 ()
  • B144MPC125B2 ()
  • B144MPC125B1 ()
  • B144MPC125B0 ()
  • B144MPC125B4 ()
MPC-125B

  • Luer-formatted disinfection cap

Clear Guide SteriGRID - B201CGSG0

The device is a needle guide grid for image-guided transperineal procedures. The device is intended to guide needle placements during endorectal ultrasound and MR/CT-guided interventions. The device is intended for use in a clinical setting. The device is intended as a disposable accessory to Clear Guide TP Access Tool (CG-PAT)
CLEAR GUIDE MEDICAL, INC.
CGSG
In Commercial Distribution

  • B201CGSG0 ()
  • B201CGSG1 ()
  • B201CGSG2 ()
  • B201CGSG3 ()
  • B201CGSG4 ()

  • Needle Gauge: 14 Gauge
CG-SG

  • Needle guide, single-use

Easy Glide 20cc Luer Lock Syringe - B2086720200

Easy Glide 20cc Luer Lock Syringe
GLOBAL DIABETIC DISTRIBUTORS INC
672020
In Commercial Distribution

  • B2086720203 ()
  • B2086720201 ()
  • B2086720200 ()
  • B2086720204 ()
  • B2086720205 ()


  • General-purpose syringe, single-use

AHS - B031AH03M30130

SYRINGE,3/10CC,30G X 5/16",U-100 INSULIN
American Health Service Sales Corporation
AH03M3013
In Commercial Distribution

  • B031AH03M30131 ()
  • B031AH03M30130 ()
  • B031AH03M30132 ()
  • B031AH03M301301 ()
  • B031AH03M301302 ()


  • Insulin syringe/needle, basic

CONNECTOR, Y 3/8" X 1/4" X 3/8" - B066C460S0

A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C460S
In Commercial Distribution

  • B066C460S0 ()
  • B066C460S6 ()
  • B066C460S5 ()
  • B066C460S4 ()
  • B066C460S3 ()
C460S

  • Non-ISO80369-standardized small-bore multichannel connector, single-use

CONNECTOR, Y 3/8" X 1/4" X 3/8" - B066C460B1

A plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C460B
In Commercial Distribution

  • B066C460B1 ()
  • B066C460B5 ()
  • B066C460B3 ()
  • B066C460B2 ()
  • B066C460B0 ()
  • B066C4604 ()
C460B

  • Non-ISO80369-standardized small-bore multichannel connector, single-use

CONNECTOR, Y 1/2" X 3/8" X 3/8" W/LUER - B066C445S0

A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C445S
In Commercial Distribution

  • B066C445S0 ()
  • B066C445S6 ()
  • B066C445S5 ()
  • B066C445S4 ()
  • B066C445S3 ()
C445S

  • Non-ISO80369-standardized small-bore multichannel connector, single-use

CONNECTOR, Y 1/2" X 3/8" X 3/8" W/LUER - B066C445B1

A plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C445B
In Commercial Distribution

  • B066C445B1 ()
  • B066C445B5 ()
  • B066C445B4 ()
  • B066C445B3 ()
  • B066C445B2 ()
  • B066C445B0 ()
C445B

  • Non-ISO80369-standardized small-bore multichannel connector, single-use

CONNECTOR, Y 1/2" X 3/8" X 3/8" - B066C440S0

A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C440S
In Commercial Distribution

  • B066C440S0 ()
  • B066C440S6 ()
  • B066C440S5 ()
  • B066C440S4 ()
  • B066C440S3 ()
C440S

  • Non-ISO80369-standardized small-bore multichannel connector, single-use

CONNECTOR, Y 3/8" X 1/4" X 1/4" W/LUER - B066C435S0

A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C435S
In Commercial Distribution

  • B066C435S0 ()
  • B066C435S6 ()
  • B066C435S5 ()
  • B066C435S4 ()
  • B066C435S3 ()
C435S

  • Non-ISO80369-standardized small-bore multichannel connector, single-use

CONNECTOR, Y 3/8" X 1/4" X 1/4" - B066C430S0

A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C430S
In Commercial Distribution

  • B066C430S0 ()
  • B066C430S6 ()
  • B066C430S5 ()
  • B066C430S4 ()
  • B066C430S3 ()
C430S

  • Non-ISO80369-standardized small-bore multichannel connector, single-use

CONNECTOR, Y 1/4" X 3/16" X 3/16" - B066C420S0

A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C420S
In Commercial Distribution

  • B066C420S0 ()
  • B066C420S5 ()
  • B066C420S4 ()
  • B066C420S3 ()
  • B066C420S6 ()
C420S

  • Non-ISO80369-standardized small-bore multichannel connector, single-use

CONNECTOR, Y 1/4" X 3/16" X 3/16" - B066C420B1

A plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C420B
In Commercial Distribution

  • B066C420B1 ()
  • B066C420B5 ()
  • B066C420B4 ()
  • B066C420B3 ()
  • B066C420B2 ()
  • B066C420B0 ()
C420B

  • Non-ISO80369-standardized small-bore multichannel connector, single-use

CONNECTOR, EQUAL Y 1/2" W/LUER - B066C345S0

A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C345S
In Commercial Distribution

  • B066C345S0 ()
  • B066C345S6 ()
  • B066C345S5 ()
  • B066C345S4 ()
  • B066C345S3 ()
C345S

  • Non-ISO80369-standardized small-bore multichannel connector, single-use

CONNECTOR, EQUAL Y 3/8" - B066C340S0

A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C340S
In Commercial Distribution

  • B066C340S0 ()
  • B066C340S6 ()
  • B066C340S5 ()
  • B066C340S4 ()
  • B066C340S3 ()
C340S

  • Non-ISO80369-standardized small-bore multichannel connector, single-use

CONNECTOR, EQUAL Y 1/2" - B066C340B1

A plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C340B
In Commercial Distribution

  • B066C340B1 ()
  • B066340B5 ()
  • B066C340B4 ()
  • B066340B3 ()
  • B066340B2 ()
  • B066C340B0 ()
C340B

  • Non-ISO80369-standardized small-bore multichannel connector, single-use

CONNECTOR, EQUAL Y 3/8" W/LUER - B066C335S0

A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C335S
In Commercial Distribution

  • B066C335S0 ()
  • B066C335S6 ()
  • B066C335S5 ()
  • B066C335S4 ()
  • B066C335S3 ()
C335S

  • Non-ISO80369-standardized small-bore multichannel connector, single-use

CONNECTOR, EQUAL Y 3/8" W/LUER - B066C335B1

A plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C335B
In Commercial Distribution

  • B066C335B1 ()
  • B066C335B5 ()
  • B066C335B4 ()
  • B066C335B3 ()
  • B066C335B2 ()
  • B066C335B0 ()
C335B

  • Non-ISO80369-standardized small-bore multichannel connector, single-use

CONNECTOR, EQUAL Y 3/8" - B066C330S0

A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C330S
In Commercial Distribution

  • B066C330S0 ()
  • B066C330S6 ()
  • B066C330S5 ()
  • B066C330S4 ()
  • B066C330S3 ()
C330S

  • Non-ISO80369-standardized small-bore multichannel connector, single-use

CONNECTOR, EQUAL Y 1/4" W/LUER - B066C325S0

A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C325S
In Commercial Distribution

  • B066C325S0 ()
  • B066C325S3 ()
  • B066C325S6 ()
  • B066C325S5 ()
  • B066C325S4 ()
C325S

  • Non-ISO80369-standardized small-bore multichannel connector, single-use
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