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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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Spetzler - OMT - M731100010

Neuro Pattie; Sterile; X-Ray detectable; Tissue Compatible Rayon; For Single Use.
OMT, LLC
Neuro Patties
In Commercial Distribution

  • M7311100169 ()
  • M731100010 ()
  • M7311100159 ()
  • K900005 ()
  • M7311100189 ()
ALL

  • Cottonoid pad

Axiom® Lig-A-Loops® - M6651140

Retraction Tape, Maxi, Blue, Veins
AXIOM MEDICAL, INCORPORATED
114
In Commercial Distribution

  • M6651145 ()
  • M6651143 ()
  • M6651141 ()
  • M6651140 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Loops® - M6651130

Retraction Tape, Maxi, White, Nerves
AXIOM MEDICAL, INCORPORATED
113
In Commercial Distribution

  • M6651135 ()
  • M6651133 ()
  • M6651131 ()
  • M6651130 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Loops® - M6651120

Retraction Tape, Maxi, Yellow, Ureters
AXIOM MEDICAL, INCORPORATED
112
In Commercial Distribution

  • M6651125 ()
  • M6651123 ()
  • M6651121 ()
  • M6651120 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Loops® - M6651110

Retraction Tape, Maxi, Red, Arteries
AXIOM MEDICAL, INCORPORATED
111
In Commercial Distribution

  • M6651115 ()
  • M6651113 ()
  • M6651111 ()
  • M6651110 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Boots® - M6653010

Instrument Jaw Covers, Multi-Color Pack
AXIOM MEDICAL, INCORPORATED
301
In Commercial Distribution

  • M6653013 ()
  • M6653011 ()
  • M6653010 ()
  • M6653015 ()


  • Vascular booties

Axiom® Lig-A-Boots® - M6653000

Instrument Jaw Covers, White
AXIOM MEDICAL, INCORPORATED
300
In Commercial Distribution

  • M6653003 ()
  • M6653001 ()
  • M6653000 ()
  • M6653005 ()


  • Vascular booties

Axiom® Lig-A-Loops® - M6651180

Retraction Tape, Mini, Blue, Veins
AXIOM MEDICAL, INCORPORATED
118
In Commercial Distribution

  • M6651185 ()
  • M6651183 ()
  • M6651181 ()
  • M6651180 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Loops® - M6651170

Retraction Tape, Mini, White, Nerves
AXIOM MEDICAL, INCORPORATED
117
In Commercial Distribution

  • M6651175 ()
  • M6651173 ()
  • M6651171 ()
  • M6651170 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Loops® - M6651160

Retraction Tape, Mini, Yellow, Ureters
AXIOM MEDICAL, INCORPORATED
116
In Commercial Distribution

  • M6651165 ()
  • M6651163 ()
  • M6651161 ()
  • M6651160 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Loops® - M6651150

Retraction Tape, Mini, Red, Arteries
AXIOM MEDICAL, INCORPORATED
115
In Commercial Distribution

  • M6651155 ()
  • M6651153 ()
  • M6651151 ()
  • M6651150 ()


  • Surgical support tape, non-bioabsorbable

TriPhasix™ - M595S4000

1lb. TriPhasix™ Chromatic Alginate
PARKELL, INC.
S400
Not in Commercial Distribution

  • M595S4043 ()
  • M595S4000 ()
  • M595S4022 ()
  • M595S4011 ()
S400

  • Silicone dental impression material

Ch24 round silicone catheter - M640R99000990011

No Description
RAND SPA
001
In Commercial Distribution

  • M640R99000990012 ()
  • M640R99000990011 ()
  • M640R99000990013 ()
  • M640R99000990014 ()

  • Length: 600 Millimeter
  • Catheter Gauge: 24 French
R9900099

  • Multi-purpose percutaneous abdominothoracic drainage catheter

Ch24 round silicone catheter - M640R99000990001

No Description
RAND SPA
000
Not in Commercial Distribution

  • M640R99000990001 ()
  • M640R99000990002 ()
  • M640R99000990003 ()
  • M640R99000990004 ()

  • Length: 600 Millimeter
  • Catheter Gauge: 24 French
R9900099

  • Multi-purpose percutaneous abdominothoracic drainage catheter

Stradis Medical, LLC. - M752IN90090

Rope And Hook
STRADIS MEDICAL, LLC
IN9009
In Commercial Distribution

  • M752IN90095 ()
  • M752IN90090 ()
  • M752IN90093 ()
  • M752IN90096 ()


  • General surgical procedure kit, non-medicated, single-use

Stradis Medical, LLC - M752HCT1CCSFST0

1CC SLIP TIP SYRINGES SILICON FREE
STRADIS MEDICAL LLC
HCT1CCSF-ST
In Commercial Distribution

  • M752HCT1CCSFST5 ()
  • M752HCT1CCSFST1 ()
  • M752HCT1CCSFST0 ()
  • M752HCT1CCSFST6 ()


  • General-purpose syringe, single-use

SUPARTZ® sodium hyaluronate - M717715655550

SUPARTZ (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. SUPARTZ is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from rooster combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. SUPARTZ is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution).
SEIKAGAKU CORPORATION
89130-5555-01
Not in Commercial Distribution

  • M717715655554 ()
  • M717715655553 ()
  • M717715655552 ()
  • M717715655550 ()
7156-5555

  • Synovial fluid supplementation medium

SUPARTZ FX sodium hyaluronate - M717715644440

SUPARTZ FX (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. SUPARTZ FX is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from chicken combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. SUPARTZ FX is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution).
SEIKAGAKU CORPORATION
89130-4444-1
In Commercial Distribution

  • M717715644440 ()
  • M717715644442 ()
  • M717715644443 ()
  • M717715644444 ()
7156-4444

  • Synovial fluid supplementation medium

QuickProfile™ Amphetamine Test Card - M90174014

Immunoassay for the detection of amphetamine in human urine
LUMIQUICK DIAGNOSTICS, INC.
74014
In Commercial Distribution

  • M90174014 ()
  • M901740141 ()
  • M901740143 ()
  • M901740142 ()

  • Length: 75 Millimeter
74014

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

InoMesh - MDLXMAG120200

MAG1-2020: 20cm x 20cm (8in x 8in) Mesh Hernia Mesh Polyvinylidene fluoride/Polybutylene adipate
MEDLINX ACACIA PTE. LTD.
MAG1-2020
In Commercial Distribution

  • MDLXMAG120200 ()
  • MDLXMAG120203 ()
  • MDLXMAG120202 ()
  • MDLXMAG120201 ()
MAG1-2020

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

InoMesh - MDLXMAG115150

MAG1-1515: 15cm x 15cm (6in x 6in) Mesh Hernia Mesh Polyvinylidene fluoride/Polybutylene adipate
MEDLINX ACACIA PTE. LTD.
MAG1-1515
In Commercial Distribution

  • MDLXMAG115150 ()
  • MDLXMAG115153 ()
  • MDLXMAG115152 ()
  • MDLXMAG115151 ()
MAG1-1515

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

InoMesh - MDLXMAG120300

MAG1-2030: 20cm x 30cm (8in x 12in) Mesh Hernia Mesh Polyvinylidene fluoride/Polybutylene adipate
MEDLINX ACACIA PTE. LTD.
MAG1-2030
In Commercial Distribution

  • MDLXMAG120300 ()
  • MDLXMAG120303 ()
  • MDLXMAG120302 ()
  • MDLXMAG120301 ()
MAG1-2030

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

InoMesh - MDLXMAG115200

MAG1-1520: 15cm x 20cm (6in x 8in) Mesh Hernia Mesh Polyvinylidene fluoride/Polybutylene adipate
MEDLINX ACACIA PTE. LTD.
MAG1-1520
In Commercial Distribution

  • MDLXMAG115200 ()
  • MDLXMAG115203 ()
  • MDLXMAG115202 ()
  • MDLXMAG115201 ()
MAG1-1520

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

InoMesh - MDLXMAG115100

MAG1-1510: 15cm x 10cm (6in x 4in) Mesh Hernia Mesh Polyvinylidene fluoride/Polybutylene adipate
MEDLINX ACACIA PTE. LTD.
MAG1-1510
In Commercial Distribution

  • MDLXMAG115100 ()
  • MDLXMAG115103 ()
  • MDLXMAG115102 ()
  • MDLXMAG115101 ()
MAG1-1510

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

BE 125-1TD Disposable Tee Adapter - M996BE1251TD0

The BE 125-1TD Tee Adapter is intended for use in a ventilator, oxygen or BIPAP circuit. Can be used to easily add a monitoring device such as a temperature probe to the breathing circuit. Dimensions: 22mm O.D. x 22mm I.D. x 15mm I.D. Single Patient Use. Molded of High Density Polyethylene.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 125-1TD
In Commercial Distribution

  • M996BE1251TD6 ()
  • M996BE1251TD0 ()
  • M996BE1251TD3 ()
  • M996BE1251TD2 ()
BE 125-1TD

  • Straight/elbow breathing circuit connector, single-use

BE 102 Swivel Tubing Clamp - M996BE1020

Ventilator Tubing Accessory - Swivel Tubing Clamp. Swivels 360 degrees; fits tubing and rails 1/2" to 1" inch diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 102
In Commercial Distribution

  • M996BE1026 ()
  • M996BE1020 ()
  • M996BE1025 ()
  • M996BE1023 ()
BE 102

  • Ventilator breathing circuit, single-use

Plasdent Fluid Proof Earloop Mask - D832MK14

FLUIDPROOF (TM) Earloop Mask - Green (50pcs/box)
PLASDENT CORPORATION
MK1
In Commercial Distribution

  • D832MK145 ()
  • D832MK14 ()
  • D832MK141 ()
  • D832MK142 ()
MK1-4

  • Surgical/medical respirator, antimicrobial

Plasdent Fluid Proof Earloop Mask - D832MK13

FLUIDPROOF (TM) Earloop Mask - Yellow (50pcs/box)
PLASDENT CORPORATION
MK1
In Commercial Distribution

  • D832MK135 ()
  • D832MK13 ()
  • D832MK131 ()
  • D832MK132 ()
MK1-3

  • Surgical/medical respirator, antimicrobial

Plasdent Fluid Proof Earloop Mask - D832MK12

FLUIDPROOF (TM) Earloop Mask - Blue (50pcs/box)
PLASDENT CORPORATION
MK1
In Commercial Distribution

  • D832MK125 ()
  • D832MK12 ()
  • D832MK121 ()
  • D832MK122 ()
MK1-2

  • Surgical/medical respirator, antimicrobial

Plasdent Fluid Proof Earloop Mask - D832MK110

FLUIDPROOF (TM) Earloop Mask - Lavender (50pcs/box)
PLASDENT CORPORATION
MK1
In Commercial Distribution

  • D832MK1101 ()
  • D832MK110 ()
  • D832MK1105 ()
  • D832MK1102 ()
MK1-10L

  • Surgical/medical respirator, antimicrobial

Plasdent Fluid Proof Earloop Mask - D832MK11

FLUIDPROOF (TM) Earloop Mask - White (50pcs/box)
PLASDENT CORPORATION
MK1
In Commercial Distribution

  • D832MK115 ()
  • D832MK11 ()
  • D832MK111 ()
  • D832MK112 ()
MK1-1

  • Surgical/medical respirator, antimicrobial

AuraLay XF Pit and Fissure Sealant - D820ALAYXFOW0

Pit and Fissure Sealant, Dental.
DENALI CORPORATION
1.2 mL Opaque White
In Commercial Distribution

  • D820ALAYXFOW0 ()
  • D820ALAYXFOW3 ()
  • D820ALAYXFOW2 ()
  • D820ALAYXFOW1 ()
ALAYXFOW

  • Dental pit/fissure sealant

AuraLay XF Pit and Fissure Sealant - D820ALAYXFNT0

Pit and Fissure Sealant, Dental.
DENALI CORPORATION
1.2 mL Natural Translucent
In Commercial Distribution

  • D820ALAYXFNT0 ()
  • D820ALAYXFNT3 ()
  • D820ALAYXFNT2 ()
  • D820ALAYXFNT1 ()
ALAYXFNT

  • Dental pit/fissure sealant

AuraLay Pit and Fissure Sealant - D820ALAYOW0

Pit and Fissure Sealant, Dental.
DENALI CORPORATION
Opaque White
In Commercial Distribution

  • D820ALAYOW0 ()
  • D820ALAYOW3 ()
  • D820ALAYOW2 ()
  • D820ALAYOW1 ()


  • Dental pit/fissure sealant

AuraLay Pit & Fissure Sealant - D820ALAYNT0

Pit and Fissure Sealant, Dental.
DENALI CORPORATION
1.2 mL Natural Translucent
In Commercial Distribution

  • D820ALAYNT0 ()
  • D820ALAYNT1 ()
  • D820ALAYNT3 ()
  • D820ALAYNT2 ()
ALAYNT

  • Dental pit/fissure sealant

Generic - D830551442PC9

TYVEK ROLL 12"X200'
GS Medical Packaging Inc
551442PC
In Commercial Distribution

  • D830551442PC0 ()
  • D830551442PC9 ()
  • D830551442PC8 ()
  • D830551442PC7 ()


  • Sterilization packaging, single-use

Generic - D830551436PC9

TYVEK ROLL 6"X200'
GS Medical Packaging Inc
551436PC
In Commercial Distribution

  • D830551436PC0 ()
  • D830551436PC9 ()
  • D830551436PC8 ()
  • D830551436PC6 ()


  • Sterilization packaging, single-use

coDiagnostiX - D835CODX1

Dental surgery treatment planning software
Dental Wings GmbH
10
In Commercial Distribution

  • D835CODX200 ()
  • D835CODX1 ()
  • D835CODX201 ()
  • D835CODX202 ()


  • Diagnostic x-ray digital imaging system workstation

coDiagnostiX - D835CDX1

Dental implant planning software
Dental Wings GmbH
9
Not in Commercial Distribution

  • D835CDX202 ()
  • D835CDX1 ()
  • D835CDX201 ()
  • D835CDX200 ()


  • Diagnostic x-ray digital imaging system workstation

MARK3 - D79690131

Alginate Alternative 380 Fast Set 2/pk. - MARK3®*
CARGUS INTERNATIONAL, INC
9013
In Commercial Distribution

  • D7969013 ()
  • D79690131 ()
  • D79690132 ()
  • D79690133 ()
  • D79690134 ()
9013

  • Silicone dental impression material
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