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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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Multi pack of 50 tampons, 10 Light, 20 Regular and 20 Super absorbency
AL-BAD MASSUOT YITZHAK LTD
BRAAC50
In Commercial Distribution

  • 10011822214152 ()
  • 00011822214155 ()

  • Absorbency


  • Menstrual tampon, unscented
Pouch of 1 sterile 20 mL syringe, stored inside a box of 20
CONCERT MEDICAL, LLC
HFS-SYR
In Commercial Distribution

  • 00814384020383 ()
  • 00814384020390 ()
411987-001

  • Pain management medication delivery system
Gel Large Bariatric Crutch Pad: 20"L x 20"W x 1"T
Coulmed Products Group LLC
GP105-1
In Commercial Distribution

  • 10810087350984 ()
GP105-1

  • Operating table patient pressure distribution pad, reusable
20 mL of 0.9% Sodium Chloride Injection USP in a 20 mL syringe
Medxl Inc
3706US
In Commercial Distribution

  • 10682686004762 ()
  • 20682686004769 ()
  • 30682686004766 ()

  • 20 mL fill in 20 mL syringe
  • Total Volume: 20 Milliliter
3706US

  • Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial
CORE BUILD-UP MATERIAL - DUAL CURE, FLUORIDE RELEASING KIT: 20 gm base + 20 gm dual catalyst, 20 core forms, mixing pad, spatulas
PULPDENT CORPORATION
HC
Not in Commercial Distribution

  • D701HC2 ()

  • Weight: 20 Gram


  • Dental composite resin
No Description
Design Eyewear Group International A/S
FFBOCCAPIXIES2/1946
In Commercial Distribution

  • 03663524273533 ()


  • Tinted non-prescription spectacles
ABSORBENT POINTS (100/box) Type: .06 Taper, Size: 20; For more information: https://www.scottsdental.com/catalog/product/view/id/30500/s/tapered-asorbent-points-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
103-9203
In Commercial Distribution

  • D77810392030 ()
  • D77810392031 ()
103-9203

  • Endodontic paper point
ABSORBENT POINTS (100/box) Type: .04 Taper, Size: 20; For more information: https://www.scottsdental.com/catalog/product/view/id/30500/s/tapered-asorbent-points-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
103-9194
In Commercial Distribution

  • D77810391940 ()
  • D77810391941 ()
103-9194

  • Endodontic paper point
GUTTA PERCHA POINTS (100/box) Type: .04 Taper, Size: 20; For more information: https://www.scottsdental.com/catalog/product/view/id/23535/s/tapered-gutta-percha-points-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
103-9172
In Commercial Distribution

  • D77810391720 ()
  • D77810391721 ()
103-9172

  • Natural gutta-percha
GUTTA PERCHA POINTS (100/box) Type: .04 Taper, Size: 20; For more information: https://www.scottsdental.com/catalog/product/view/id/23535/s/tapered-gutta-percha-points-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
103-9152
In Commercial Distribution

  • D77810391520 ()
  • D77810391521 ()
103-9152

  • Natural gutta-percha
ABSORBENT POINTS (180/box) Type: Cell Pack, Size: 20; For more information: https://www.scottsdental.com/catalog/product/view/id/23513/s/absorbent-points-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
103-9104
In Commercial Distribution

  • D77810391040 ()
  • D77810391041 ()
103-9104

  • Endodontic paper point
AZUR 18 Detachable Helical HydroCoil
MICROVENTION INC.
45-482020-02
In Commercial Distribution

  • 00842429120705 ()

  • 20 mm x 20 cm
45-482020

  • Non-neurovascular embolization coil
Azur
MICROVENTION INC.
45-482020
In Commercial Distribution

  • 00810170018077 ()

  • 20 mm x 20 cm
45-482020

  • Non-neurovascular embolization coil
Azur
MICROVENTION INC.
45-452020
In Commercial Distribution

  • 00810170015038 ()

  • 20 mm x 20 cm
45-452020

  • Non-neurovascular embolization coil
Azur
MICROVENTION INC.
45-482020
In Commercial Distribution

  • 00810170012686 ()

  • 20 mm x 20 cm
45-482020

  • Non-neurovascular embolization coil
V-Trak
MICROVENTION INC.
182020HES-V
In Commercial Distribution

  • 00810170011542 ()

  • 20 mm x 20 cm
182020HES-V

  • Neurovascular embolization coil
RIVA LUTING PLUS 50 CAP
SDI LIMITED
8651008
In Commercial Distribution

  • 09336472017071 ()
8651008

  • Glass ionomer dental cement
RIVA LUTING LY 50 CAP
SDI LIMITED
8650008
In Commercial Distribution

  • 09336472016906 ()
8650008

  • Glass ionomer dental cement
PTH Intact - CENTAUR - CAL - 2x2x1mL
Siemens Healthcare Diagnostics Inc.
10492394
In Commercial Distribution

  • 00630414579207 ()
10492394

  • Parathyroid hormone (PTH) IVD, calibrator
PTH Intact - CENTAUR - CAL - 6x2x1mL
Siemens Healthcare Diagnostics Inc.
10492387
In Commercial Distribution

  • 00630414579191 ()
10492387

  • Parathyroid hormone (PTH) IVD, calibrator
PTH Intact - CENTAUR - CTL - 3x2x2mL
Siemens Healthcare Diagnostics Inc.
10492378
In Commercial Distribution

  • 00630414579184 ()
10492378

  • Parathyroid hormone (PTH) IVD, control
PTH Intact Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10492373
In Commercial Distribution

  • 00630414579177 ()
10492373

  • Parathyroid hormone (PTH) IVD, control
AdviseDx SARS-CoV-2 IgG II Control Kit
Abbott Ireland Diagnostics
06S6110
In Commercial Distribution

  • 00380740193829 ()
06S6110

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
AdviseDx SARS-CoV-2 IgG II Calibrator Kit
Abbott Ireland Diagnostics
06S6101
In Commercial Distribution

  • 00380740193805 ()
06S6101

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
AdviseDx SARS-CoV-2 IgG II Control Kit
Abbott Ireland Diagnostics
06S6010
In Commercial Distribution

  • 00380740193744 ()
06S6010

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
AdviseDx SARS-CoV-2 IgG II Calibrator Kit
Abbott Ireland Diagnostics
06S6001
In Commercial Distribution

  • 00380740193720 ()
06S6001

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
ARCHITECT STAT High Sensitivity Troponin-I Controls
ABBOTT IRELAND
02R9810
In Commercial Distribution

  • 00380740175481 ()
02R9810

  • Troponin I IVD, control
Alinity i STAT CK-MB Calibrators
Abbott Ireland Diagnostics
04V3801
In Commercial Distribution

  • 00380740165482 ()
04V3801

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator
The Fresh Whole Blood Donor Set contains everything needed to properly document donor information, screen for ABO/Rh, collect samples for retrospective testing and perform the collection of one unit of fresh whole blood in a compact sealed package. The transfusion of fresh whole blood is the best option for management of casualties with hemorrhagic shock. Blood transfusions have been used successfully in military conflicts and other austere conditions to resuscitate trauma patients suffering from shock due to hemorrhage.
Safeguard US Operating, LLC
15
In Commercial Distribution

  • M68980801D150 ()
80-801-D

  • Blood donor set, single-pack
The Fresh Whole Blood Donor Set contains everything needed to properly document donor information, screen for ABO/Rh, collect samples for retrospective testing and perform the collection of one unit of fresh whole blood in a compact sealed package. The transfusion of fresh whole blood is the best option for management of casualties with hemorrhagic shock. Blood transfusions have been used successfully in military conflicts and other austere conditions to resuscitate trauma patients suffering from shock due to hemorrhage.
Safeguard US Operating, LLC
14
In Commercial Distribution

  • M68980801D140 ()
80-801-D

  • Blood donor set, single-pack
FRESH WHOLE BLOOD DONOR SET Constricting Band (18”x1”) 1 ea Alcohol Pads 2 ea Gauze Sponge 2 ea Chlorhexidine Swab 1 ea Blood Tube- Lavender Top 4 ea Kelly Clamp 1 ea Blood Tube- Red Top 2 ea Nylon Cord (10”) 1 ea Blood Collection Needle 1 ea Beaded Cable Tie 1 ea Surgical Tape 1 ea Permanent Marker 1 ea Clear IV Dressing 1 ea ASBP 572 1 ea ABO/Rh Screen (EldonCard) 1 ea Blood Bag Label 1 ea Blood Collection Bag 1 ea Instructions for Use 1 ea Gloves (Pair) 1 ea
Safeguard US Operating, LLC
11
Not in Commercial Distribution

  • M68980801D110 ()
80-801-D

  • Blood donor set, single-pack
FRESH WHOLE BLOOD DONOR SET Constricting Band (18”x1”) 1 ea Alcohol Pads 2 ea Gauze Sponge (4”x4”) 2 ea Chlorhexidine Swab 1 ea Blood Tube- Lavender Top 4 ea 5.5” Kelly Clamp 1 ea Blood Tube- Red Top 2 ea Nylon Cord (10”) 1 ea Blood Collection Needle 21gx1.25" 1 ea Beaded Cable Tie 1 ea Surgical Tape 1 ea Permanent Marker 1 ea Clear IV Dressing 1 ea ASBP 572 1 ea ABO/Rh Screen (EldonCard) 1 ea Blood Bag Label 1 ea Blood Collection Bag 1 ea Instructions for Use 1 ea Gloves (Pair) 1 ea
Safeguard US Operating, LLC
09
In Commercial Distribution

  • M68980801D090 ()
80-801-D

  • Blood donor set, single-pack
FRESH WHOLE BLOOD DONOR SET Constricting Band (18”x1”) 1 ea Alcohol Pads 2 ea Gauze Sponge (4”x4”) 2 ea Chlorhexidine Swab 1 ea Blood Tube- Lavender Top 4 ea 5.5” Kelly Clamp 1 ea Blood Tube- Red Top 2 ea Nylon Cord (10”) 1 ea Blood Collection Needle 21gx1.25" 1 ea Beaded Cable Tie 1 ea Surgical Tape 1 ea Permanent Marker 1 ea Clear IV Dressing 1 ea ASBP 572 1 ea ABO/Rh Screen (EldonCard) 1 ea Blood Bag Label 1 ea Blood Collection Bag 1 ea Instructions for Use 1 ea Gloves (Pair) 1 ea
Safeguard US Operating, LLC
8
Not in Commercial Distribution

  • M68980801D080 ()
80-801-D

  • Blood donor set, single-pack
FRESH WHOLE BLOOD DONOR SET Constricting Band (18”x1”) 1 ea Alcohol Pads 2 ea Gauze Sponge (4”x4”) 2 ea Chlorhexidine Swab 1 ea Blood Tube- Lavender Top 4 ea 5.5” Kelly Clamp 1 ea Blood Tube- Red Top 2 ea Nylon Cord (10”) 1 ea Blood Collection Needle 21gx1.25" 1 ea Beaded Cable Tie 1 ea Surgical Tape 1 ea Permanent Marker 1 ea Clear IV Dressing 1 ea ASBP 572 1 ea ABO/Rh Screen (EldonCard) 1 ea Blood Bag Label 1 ea Blood Collection Bag 1 ea Instructions for Use 1 ea Gloves (Pair) 1 ea
Safeguard US Operating, LLC
7
Not in Commercial Distribution

  • M68980801D070 ()
80-801-D

  • Blood donor set, single-pack
FRESH WHOLE BLOOD DONOR SET Constricting Band (18”x1”) 1 ea Gloves (Pair) 1 ea Gauze Sponge (4”x4”) 2 ea Alcohol Pads 2 ea Blood Tube- Lavender Top 4 ea Chlorhexidine Swab 1 ea Blood Tube- Red Top 2 ea 5.5” Kelly Clamp 1 ea Blood Collection Needle 21gx1.25" 1 ea Nylon Cord (10”) 1 ea Surgical Tape 1 ea Permanent Marker 1 ea Clear IV Dressing 1 ea ASBP 572 1 ea ABO/Rh Screen (EldonCard) 1 ea Blood Bag Label 1 ea Blood Collection Bag 1 ea Instructions for Use 1 ea
Safeguard US Operating, LLC
4
Not in Commercial Distribution

  • M68980801D040 ()
80-801-D

  • Blood donor set, single-pack
Designed for missions in the most remote and austere environments, the Fresh Whole Blood Donor Set contains essential items to collect and transfuse fresh whole blood in a compact sealed package. In remote areas and combat environments where definitive care may be too far away or inaccessible, transfusion of fresh whole blood may be the best option for management of hemorrhagic shock in casualties. Blood transfusions have been used successfully in military conflicts and other austere conditions to resuscitate trauma patients suffering from hemorrhagic shock. Developed with extensive research and feedback from the Armed Services Blood Program Office, the Fresh Whole Blood Donor Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood Donor in a compact sealed package. NOTE: Only personnel trained in blood collection, transfusion, and management of transfusion reactions should use this set. Combat Capabilities • Easily administered • Simplifies training • Compact lightweight • Cost effective Product Attributes • 100% TAA compliant components (no waivers required) DONOR SET- PN: 80-801-D is: • Assembled in GMP facility. • Adhesive blood bag label for recording donor information. • EldonCard™: ABO/Rh blood-typing card for simple, accurate, and fast results. • Re-sealable bag used to send all supplies back with casualty for retrospective testing. DONOR SET- PN: 80-801-D • Constricting Band (18”x1”) 1 ea Gloves (Pair) 1 ea • Gauze Sponge (4”x4”) 2 ea Alcohol Pads 2 ea • Blood Tube- Pearl Top 3 ea Chloraprep Swabstick 1 ea • Blood Tube- Gold Top 2 ea 5.5” Kelly Clamp 1 ea • Blood Tube- Lavender Top 1 ea Nylon Cord (10”) 1 ea • Blood Collection Needle 1 ea
Safeguard US Operating, LLC
2
Not in Commercial Distribution

  • M68980801D020 ()
80-801-D

  • Blood donor set, single-pack
Designed for missions in the most remote and austere environments, the Fresh Whole Blood Donor Set contains essential items to collect and transfuse fresh whole blood in a compact sealed package. In remote areas and combat environments where definitive care may be too far away or inaccessible, transfusion of fresh whole blood may be the best option for management of hemorrhagic shock in casualties. Blood transfusions have been used successfully in military conflicts and other austere conditions to resuscitate trauma patients suffering from hemorrhagic shock. Developed with extensive research and feedback from the Armed Services Blood Program Office, the Fresh Whole Blood Donor Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood Donor in a compact sealed package. NOTE: Only personnel trained in blood collection, transfusion, and management of transfusion reactions should use this set. Combat Capabilities • Easily administered • Simplifies training • Compact lightweight • Cost effective Product Attributes • 100% TAA compliant components (no waivers required) DONOR SET- PN: 80-801-D is: • Assembled in GMP facility. • Adhesive blood bag label for recording donor information. • EldonCard™: ABO/Rh blood-typing card for simple, accurate, and fast results. • Re-sealable bag used to send all supplies back with casualty for retrospective testing. DONOR SET- PN: 80-801-D • Constricting Band (18”x1”) 1 ea Gloves (Pair) 1 ea • Gauze Sponge (4”x4”) 2 ea Alcohol Pads 2 ea • Blood Tube- Pearl Top 3 ea Chloraprep Swabstick 1 ea • Blood Tube- Gold Top 2 ea 5.5” Kelly Clamp 1 ea • Blood Tube- Lavender Top 1 ea Nylon Cord (10”) 1 ea • Blood Collection Needle 1 ea
Safeguard US Operating, LLC
1
Not in Commercial Distribution

  • M68980801D0 ()
80-801-D

  • Blood donor set, single-pack
The Fresh Whole Blood Transfusion Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood transfusion in a compact sealed package.
Safeguard US Operating, LLC
06
In Commercial Distribution

  • M68980801060 ()
80-801

  • Blood transfusion set, non-exchange
  • Blood donor set, single-pack
FRESH WHOLE BLOOD TRANSFUSION SET Donor Set (PN 80-801-D) 1ea Recipient Set (PN 80-801-R) 1ea Instructions for Use 1ea
Safeguard US Operating, LLC
5
In Commercial Distribution

  • M68980801050 ()
80-801

  • Blood transfusion set, non-exchange
  • Blood donor set, single-pack
FRESH WHOLE BLOOD TRANSFUSION SET Donor Set (PN 80-801-D) 1ea Recipient Set (PN 80-801-R) 1ea Instructions for Use 1ea
Safeguard US Operating, LLC
4
Not in Commercial Distribution

  • M68980801040 ()
80-801

  • Blood transfusion set, non-exchange
  • Blood donor set, single-pack
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