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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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Microvials in rack, Sterile 12x4 - 07332699000645

No Description
M DIALYSIS INC.
Sterile
In Commercial Distribution

  • 07332699000645 ()
  • 07332699000980 ()
P000154

  • Microdialysis system

702 P37,IN,STD,STKR - 00840828100533

702 P37,IN,STD,STKR
CURBELL MEDICAL PRODUCTS, INC.
3001-990-786
In Commercial Distribution

  • 00840828100533 ()
197

  • Electrical mains power extension cable

IV POLE ASSY 24 IN - 00840682143707

IV POLE 24 IN
Datex-Ohmeda, Inc.
24 Inch IV1
In Commercial Distribution

  • 00840682143707 ()
6600-0491-801

  • Freestanding/bed-attached intravenous pole

IV POLE ASSY 12 IN - 00840682143684

IV POLE 12 IN
Datex-Ohmeda, Inc.
12 Inch IV1
In Commercial Distribution

  • 00840682143684 ()
0217-5378-800

  • Freestanding/bed-attached intravenous pole

STRETCHER PAD 2 IN POLYFOAM - 00733657249422

No Description
ALIMED, INC.
924945/NA/NA/74L25W
In Commercial Distribution

  • 00733657249422 ()
2970012407

  • Stretcher mattress

STRETCHER PAD 2 IN POLYFOAM - 00733657249415

No Description
ALIMED, INC.
924945/NA/NA/72L27W
In Commercial Distribution

  • 00733657249415 ()
2970012408

  • Stretcher mattress

WEDGE,OB/GYN,3 IN - 00733657239249

No Description
ALIMED, INC.
930795
In Commercial Distribution

  • 00733657239249 ()
2970013182

  • Freestanding patient positioner, reusable

BOLSTER,ANGULAR,TORSO,12.5x7.25 IN - 00733657243642

No Description
ALIMED, INC.
9-107
In Commercial Distribution

  • 00733657243642 ()
2970011583

  • Freestanding patient positioner, reusable

Perc Rod Holder, Sweep In - M739223170190

No Description
CAPTIVA SPINE, INC.
2231-7019
In Commercial Distribution

  • M739223170190 ()


  • Surgical implant/trial-implant/sizer holder, reusable

TRANSFER BOARD MAPLE 24 IN - 00733657224382

No Description
ALIMED, INC.
8502
In Commercial Distribution

  • 00733657224382 ()
2970011228

  • Patient transfer sliding board

CUSHION SSI COMBO 16x16 IN - 00733657218619

No Description
ALIMED, INC.
1201
In Commercial Distribution

  • 00733657218619 ()
2970000165

  • Wheelchair seat cushion

SMILEGOODS 3 IN 1 FLOSSERS - 00723896025994

Flosser that combines a flosser, pick, and interdental brush. Individually wrapped. 500 per pack.
PRACTICON, INC.
71098132
In Commercial Distribution

  • 00723896025994 ()
71098132

  • Dental floss

MicroCurrent Face-Lifter 6 in 1 - 04099702079632

MicroCurrent Face-Lifter 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
GESKE Beauty Tech GmbH
Magenta
In Commercial Distribution

  • 04099702079632 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system

MicroCurrent Face-Lifter 6 in 1 - 04099702079618

MicroCurrent Face-Lifter 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
GESKE Beauty Tech GmbH
Green
In Commercial Distribution

  • 04099702079618 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system

MicroCurrent Face-Lifter 6 in 1 - 04099702079519

MicroCurrent Face-Lifter 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
GESKE Beauty Tech GmbH
Gray
In Commercial Distribution

  • 04099702079519 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system

MicroCurrent Face-Lifter 6 in 1 - 04099702079496

MicroCurrent Face-Lifter 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
GESKE Beauty Tech GmbH
Black
In Commercial Distribution

  • 04099702079496 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system

MicroCurrent Face-Lifter 6 in 1 - 04099702079472

MicroCurrent Face-Lifter 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
GESKE Beauty Tech GmbH
Starlight
In Commercial Distribution

  • 04099702079472 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system

McKesson - 10612479230122

Bilateral Limb Drape 116 in x 88 in x 144 in
MCKESSON MEDICAL-SURGICAL INC.
183-i80-09138G-S
In Commercial Distribution

  • 40612479230130 ()
  • 10612479230122 ()


  • Patient surgical drape, single-use

McKesson - 10612479229843

Pediactric Laparotomy Drape 100 in x 72 in x 124 in
MCKESSON MEDICAL-SURGICAL INC.
183-i80-05212G-S
In Commercial Distribution

  • 40612479229851 ()
  • 10612479229843 ()


  • Patient surgical drape, single-use

McKesson - 10612479229829

LAVH Laparotomy Drape 112 in x 30 in x 124 in
MCKESSON MEDICAL-SURGICAL INC.
183-i80-05174G-S
In Commercial Distribution

  • 40612479229837 ()
  • 10612479229829 ()


  • Patient surgical drape, single-use

McKesson - 10612479229805

Laparotomy Drape TRANSVERSE 100 in x 72 in x 120 in
MCKESSON MEDICAL-SURGICAL INC.
183-i80-05172G-S
In Commercial Distribution

  • 40612479229813 ()
  • 10612479229805 ()


  • Patient surgical drape, single-use

McKesson - 10612479229782

Laparotomy Drape ABDOMINAL 104 in x 76 in x 120 in
MCKESSON MEDICAL-SURGICAL INC.
183-i80-05170G-S
In Commercial Distribution

  • 40612479229790 ()
  • 10612479229782 ()


  • Patient surgical drape, single-use

DeRoyal - 00749756965552

Foam Positioner, Body 18 in x11 in X8 in 6/cs
DEROYAL INDUSTRIES, INC.
M60-032A
In Commercial Distribution

  • 50749756965557 ()
  • 00749756965552 ()
M60-032A

  • Freestanding patient positioner, single-use

Walgreens - 10311917171347

Walgreens Foam Cushion. 18 in x 16 in x 3 in.
WALGREEN CO.
369356
In Commercial Distribution

  • 00311917171340 ()
  • 10311917171347 ()
  • 20311917171344 ()

  • Length: 18 Inch
  • Width: 16 Inch
  • Height: 3 Inch
WRX369356V1

  • Wheelchair seat cushion

ALL-HEALTH Adhesive Bandages - 00017276234121

Antibacterial Flexible Fabric Adhesive Bandages, assorted sizes (5/8 in x 2 /14 in; 3/4 in x 3 in; 1 in x 3 in)
Aso LLC
017276234121
In Commercial Distribution

  • 20017276234125 ()
  • 00017276234121 ()
  • 60017276234123 ()

  • Width: 1 Inch
  • Width: 0.75 Inch
  • Width: 0.62 Inch
017276234121

  • Skin-cover adhesive strip, antimicrobial

ALL-HEALTH Adhesive Bandages - 00017276234084

Flexible Fabric Adhesive Bandages, assorted sizes (5/8 in x 2 1/4 in; 3/4 in x 3 in; 1 in x 3 in)
Aso LLC
017276234084
In Commercial Distribution

  • 20017276234088 ()
  • 00017276234084 ()
  • 60017276234086 ()

  • Width: 1 Inch
  • Width: 0.75 Inch
  • Width: 0.62 Inch
017276234084

  • Skin-cover adhesive strip, non-antimicrobial

ALL-HEALTH Adhesive Bandages - 00017276234022

Flexible Fabric Adhesive Bandages, assorted sizes (5/8 in x 2 1/4 in; 3/4 in x 3 in; 1 in x 3 in)
Aso LLC
017276234022
Not in Commercial Distribution

  • 20017276234026 ()
  • 00017276234022 ()
  • 60017276234024 ()

  • Width: 1 Inch
  • Width: 0.75 Inch
  • Width: 0.62 Inch
017276234022

  • Skin-cover adhesive strip, non-antimicrobial

ALL-HEALTH Adhesive Bandages - 00017276233711

Flexible Fabric Adhesive Bandages, assorted sizes (5/8 in x 2 1/4 in; 3/4 in x 3 in; 1 in x 3 in)
Aso LLC
017276233711
Not in Commercial Distribution

  • 20017276233715 ()
  • 00017276233711 ()
  • 60017276233713 ()

  • Width: 1 Inch
  • Width: 0.75 Inch
  • Width: 0.62 Inch
017276233711

  • Skin-cover adhesive strip, non-antimicrobial

CS1304A HVG Leads - 00860009424869

Electrode Accessories, (4) - 2 in X 2 in Pad + (1) - 4 in X 7 in Pad
Control Solutions LLC
Electrode Accessories, (4) - 2 in X 2 in Pad + (1) - 4 in X 7 in Pad
In Commercial Distribution

  • 00860009424869 ()


  • Physical therapy ultrasound/neuromuscular stimulation system

RONDEX CPR REDI-SHIELD (Made in USA) in poly bag and gloves - 00634376098073

The Rondex CPR REDI-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when doing resuscitation. Barrier surface area (6" X 6") helps isolate the rescuer from the patient. The barrier material is attached to a short bite block containing one (1) silicone valve which helps to isolate the patient's breath from the rescuer. The bite block helps to keep the barrier positioned correctly while keeping the patient's mouth open. This makes ventilation much easier when doing the head tilt/chin lift procedure. The short bite block, 1/2" in length, reduces the risk of pushing the patient's tongue back and does not require a prescription. The REDI-SHIELD with a bite block advantage is very compact and is ideal for unitized packaging in first aid kits and key ring cases. This device is for emergency use only and should only be used by persons properly trained in CPR and in the use of this device. REDI-SHIELD(TM) of Rondex MADE IN USA.
RONDEX PRODUCTS, INCORPORATED
9800-G (package in poly bag with gloves)
In Commercial Distribution

9800-G

  • Cardiopulmonary resuscitation mask, single-use

RONDEX CPR REDI-SHIELD (Made in USA) in zipper key ring case - 06343760098516

The Rondex CPR REDI-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when doing resuscitation. Barrier surface area (6" X 6") helps isolate the rescuer from the patient. The barrier material is attached to a short bite block containing one (1) silicone valve which helps to isolate the patient's breath from the rescuer. The bite block helps to keep the barrier positioned correctly while keeping the patient's mouth open. This makes ventilation much easier when doing the head tilt/chin lift procedure. The short bite block, 1/2" in length, reduces the risk of pushing the patient's tongue back and does not require a prescription. The REDI-SHIELD with a bite block advantage is very compact and is ideal for unitized packaging in first aid kits and key ring cases. This device is for emergency us only and should only be used by persons properly trained in CPR and in the use of this device. REDI-SHIELD(TM) of Rondex MADE IN USA.
RONDEX PRODUCTS, INCORPORATED
9850-Z (packaged in key ring zipper case)
Not in Commercial Distribution

  • 06343760098516 ()
9850-G

  • Cardiopulmonary resuscitation mask, single-use

RONDEX CPR REDI-SHIELD (Made in USA) in poly bag and gloves - 06343760098073

The Rondex CPR REDI-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when doing resuscitation. Barrier surface area (6" X 6") helps isolate the rescuer from the patient. The barrier material is attached to a short bite block containing one (1) silicone valve which helps to isolate the patient's breath from the rescuer. The bite block helps to keep the barrier positioned correctly while keeping the patient's mouth open. This makes ventilation much easier when doing the head tilt/chin lift procedure. The short bite block, 1/2" in length, reduces the risk of pushing the patient's tongue back and does not require a prescription. The REDI-SHIELD with a bite block advantage is very compact and is ideal for unitized packaging in first aid kits and key ring cases. This device is for emergency use only and should only be used by persons properly trained in CPR and in the use of this device. REDI-SHIELD(TM) of Rondex MADE IN USA.
RONDEX PRODUCTS, INCORPORATED
9800-G (packaged in poly bag with gloves)
Not in Commercial Distribution

  • 06343760098073 ()
9800-G

  • Cardiopulmonary resuscitation mask, single-use

STRAP TWO PIECE SIDE RAIL 6 IN x 47 IN-76 IN - 00733657243932

No Description
ALIMED, INC.
91-288
In Commercial Distribution

  • 00733657243932 ()
2970011619

  • Limb/torso/head restraint, reusable

STRAP TWO PIECE SIDE RAIL 4 IN x 47 IN-76 IN - 00733657243925

No Description
ALIMED, INC.
91-287
In Commercial Distribution

  • 00733657243925 ()
2970011618

  • Limb/torso/head restraint, reusable

STRAP TWO PIECE SIDE RAIL 3 IN x 47 IN-76 IN - 00733657243918

No Description
ALIMED, INC.
91-286
In Commercial Distribution

  • 00733657243918 ()
2970011617

  • Limb/torso/head restraint, reusable

STRAP TWO PIECE SIDE RAIL 2 IN x 47 IN-76 IN - 00733657243901

No Description
ALIMED, INC.
91-285
In Commercial Distribution

  • 00733657243901 ()
2970011616

  • Limb/torso/head restraint, reusable

STRAP TWO PIECE SIDE RAIL 6 IN x 76 IN-108 IN - 00733657240528

No Description
ALIMED, INC.
932586
In Commercial Distribution

  • 00733657240528 ()
2970013595

  • Limb/torso/head restraint, reusable

STRAP TWO PIECE SIDE RAIL 4 IN x 76 IN-108 IN - 00733657240511

No Description
ALIMED, INC.
932585
In Commercial Distribution

  • 00733657240511 ()
2970013594

  • Limb/torso/head restraint, reusable

STRAP TWO PIECE SIDE RAIL 3 IN x 76 IN-108 IN - 00733657240504

No Description
ALIMED, INC.
932584
In Commercial Distribution

  • 00733657240504 ()
2970013593

  • Limb/torso/head restraint, reusable

TWIST DRILL - 00880304409842

No Description
Biomet Orthopedics, LLC
908406
In Commercial Distribution

  • 00880304409842 ()

  • DIA. 5/64 IN.(2.0MM), LENGTH: 5 IN.
908406

  • Fluted surgical drill bit, single-use

TWIST - 00880304360037

No Description
Biomet Orthopedics, LLC
35-463016
In Commercial Distribution

  • 70880304360036 ()
  • 00880304360037 ()

  • DIA. 1/4 IN.(6.4MM), LENGTH: 5 IN.
35-463016

  • Fluted surgical drill bit, reusable

TWIST - 00880304360020

No Description
Biomet Orthopedics, LLC
35-463012
In Commercial Distribution

  • 00880304360020 ()

  • DIA. 3/16 IN.(4.8MM), LENGTH: 5 IN.
35-463012

  • Fluted surgical drill bit, reusable

TWIST - 00880304360006

No Description
Biomet Orthopedics, LLC
35-463010
In Commercial Distribution

  • 70880304360005 ()
  • 00880304360006 ()

  • DIA. 5/32 IN.(4.0MM), LENGTH: 5 IN.
35-463010

  • Fluted surgical drill bit, reusable

TWIST - 00880304359987

No Description
Biomet Orthopedics, LLC
35-463008
In Commercial Distribution

  • 00880304359987 ()

  • DIA. 1/8 IN.(3.2MM), LENGTH: 5 IN.
35-463008

  • Fluted surgical drill bit, reusable

TWIST - 00880304359970

No Description
Biomet Orthopedics, LLC
35-463007
In Commercial Distribution

  • 00880304359970 ()

  • DIA. 7/64 IN.(2.7MM), LENGTH: 5 IN.
35-463007

  • Fluted surgical drill bit, reusable

TWIST - 00880304359963

No Description
Biomet Orthopedics, LLC
35-463006
In Commercial Distribution

  • 00880304359963 ()

  • DIA. 3/32 IN.(2.4MM), LENGTH: 5 IN.
35-463006

  • Fluted surgical drill bit, reusable

TWIST - 00880304359956

No Description
Biomet Orthopedics, LLC
35-463005
In Commercial Distribution

  • 70880304359955 ()
  • 00880304359956 ()

  • DIA. 5/64 IN.(2.0MM), LENGTH: 5 IN.
35-463005

  • Fluted surgical drill bit, reusable

TWIST - 00880304359949

No Description
Biomet Orthopedics, LLC
35-463004
In Commercial Distribution

  • 00880304359949 ()

  • DIA. 1/16 IN.(1.6MM), LENGTH: 5 IN.
35-463004

  • Fluted surgical drill bit, reusable

TITAN™ - 10381780258353

The Fin-Lock Punch is used to impact the bone for proper fit of the glenoid. It can also be used to further pressurize the cement.
Ascension Orthopedics, Inc.
PN-0926-001
In Commercial Distribution

  • M269PN09260011 ()
  • 10381780258353 ()

  • 8.0 in L x 1.5 in end diameter


  • Bone cutter

Integra® - 10381780247876

Integra® Total Foot System The TX 8 non-cannulated driver with AO is used in conjunction with the Integra Total Foot system.
Ascension Orthopedics, Inc.
TXDTFS08
In Commercial Distribution

  • M269TXDTFS081 ()
  • 10381780247876 ()

  • 3.5 in L x .13 in dia tip
TXD-TFS-08

  • Surgical screwdriver, reusable
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