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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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Ambler Value Line - 00190660178024

Fansler proctoscope, 2 3/8'' long x 1 1/4'' diameter, open at top
AMBLER SURGICAL CORP.
Fansler proctoscope
In Commercial Distribution

  • 00190660178024 ()
86-288

  • Rectal speculum

Ambler Surgical - 00190660178017

Fansler proctoscope, 2 3/8'' long x 1 1/4'' diameter, open at top
AMBLER SURGICAL CORP.
Fansler proctoscope
In Commercial Distribution

  • 00190660178017 ()
86-287

  • Rectal speculum

JOBST Elvarex - 04019702302431

Elvarex 2/Stump/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77350-00012-00
In Commercial Distribution

  • 04019702302431 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable

Kirwan - 00841019118139

Reusable Bipolar Forceps, 6" Working Length, Insulated to Angle, Angled Up at 3mm (Special)
KIRWAN SURGICAL PRODUCTS LLC
12-1436AUS
In Commercial Distribution

  • 00841019118139 ()


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

TRACOE® comfort - 04035324011070

Tube with 15 mm Connector and second additional inner cannula, clamp at the top
Tracoe medical GmbH
REF 105-14-1D
Not in Commercial Distribution

  • 04035324011070 ()

  • Lumen/Inner Diameter: 12.6 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use

TRACOE® comfort - 04035324011049

Tube with 15 mm Connector and second additional inner cannula, clamp at the top
Tracoe medical GmbH
REF 105-13-1D
Not in Commercial Distribution

  • 04035324011049 ()

  • Lumen/Inner Diameter: 11.8 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use

TRACOE comfort - 04035324011001

Tube with 15 mm Connector and second additional inner cannula, clamp at the top
Tracoe medical GmbH
REF 105-12-1D
In Commercial Distribution

  • 04035324011001 ()

  • Lumen/Inner Diameter: 10.8 Millimeter
REF 105-12-1D

  • Tracheostomy tube, non-reinforced, non-customized, reusable

TRACOE comfort - 04035324010974

Tube with 15 mm Connector and second additional inner cannula, clamp at the top
Tracoe medical GmbH
REF 105-11-1D
In Commercial Distribution

  • 04035324010974 ()

  • Lumen/Inner Diameter: 9.7 Millimeter
REF 105-11-1D

  • Tracheostomy tube, non-reinforced, non-customized, reusable

TRACOE comfort - 04035324010950

Tube with 15 mm Connector and second additional inner cannula, clamp at the top
Tracoe medical GmbH
REF 105-10-1D
In Commercial Distribution

  • 04035324010950 ()

  • Lumen/Inner Diameter: 8.7 Millimeter
REF 105-10-1D

  • Tracheostomy tube, non-reinforced, non-customized, reusable

TRACOE comfort - 04035324010936

Tube with 15 mm Connector and second additional inner cannula, clamp at the top
Tracoe medical GmbH
REF 105-09-1D
In Commercial Distribution

  • 04035324010936 ()

  • Lumen/Inner Diameter: 7.6 Millimeter
REF 105-09-1D

  • Tracheostomy tube, non-reinforced, non-customized, reusable

TRACOE comfort - 04035324010851

Tube with 15 mm Connector and second additional inner cannula, clamp at the top
Tracoe medical GmbH
REF 105-08-1D
In Commercial Distribution

  • 04035324010851 ()

  • Lumen/Inner Diameter: 6.8 Millimeter
REF 105-08-1D

  • Tracheostomy tube, non-reinforced, non-customized, reusable

TRACOE comfort - 04035324010820

Tube with 15 mm Connector and second additional inner cannula, clamp at the top
Tracoe medical GmbH
REF 105-07-1D
In Commercial Distribution

  • 04035324010820 ()

  • Lumen/Inner Diameter: 5.8 Millimeter
REF 105-07-1D

  • Tracheostomy tube, non-reinforced, non-customized, reusable

TRACOE comfort - 04035324010783

Tube with 15 mm Connector and second additional inner cannula, clamp at the top
Tracoe medical GmbH
REF 105-06-1D
In Commercial Distribution

  • 04035324010783 ()

  • Lumen/Inner Diameter: 4.8 Millimeter
REF 105-06-1D

  • Tracheostomy tube, non-reinforced, non-customized, reusable

TRACOE comfort - 04035324010585

Tube with 15 mm Connector and second additional inner cannula, clamp at the top
Tracoe medical GmbH
REF 105-05-1D
In Commercial Distribution

  • 04035324010585 ()

  • Lumen/Inner Diameter: 4.0 Millimeter
REF 105-05-1D

  • Tracheostomy tube, non-reinforced, non-customized, reusable

TRACOE® comfort - 04035324010554

Tube with 15 mm Connector and second additional inner cannula, clamp at the top
Tracoe medical GmbH
REF 105-04-1D
Not in Commercial Distribution

  • 04035324010554 ()

  • Lumen/Inner Diameter: 3.2 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use

TRACOE® comfort - 04035324010523

Tube with 15 mm Connector and second additional inner cannula, clamp at the top
Tracoe medical GmbH
REF 105-03-1D
Not in Commercial Distribution

  • 04035324010523 ()

  • Lumen/Inner Diameter: 2.6 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use

TRACOE® comfort - 04035324023547

Tube with 15 mm Connector and second additional inner cannula, clamp at the top
Tracoe medical GmbH
REF 888-105-14-1D
Not in Commercial Distribution

  • 04035324023547 ()

  • Lumen/Inner Diameter: 12.6 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use

TRACOE® comfort - 04035324023479

Tube with 15 mm Connector and second additional inner cannula, clamp at the top
Tracoe medical GmbH
REF 888-105-13-1D
Not in Commercial Distribution

  • 04035324023479 ()

  • Lumen/Inner Diameter: 11.8 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use

TRACOE comfort - 04035324023400

Tube with 15 mm Connector and second additional inner cannula, clamp at the top
Tracoe medical GmbH
REF 888-105-12-1D
In Commercial Distribution

  • 04035324023400 ()

  • Lumen/Inner Diameter: 10.8 Millimeter
REF 888-105-12-1D

  • Tracheostomy tube, non-reinforced, non-customized, reusable

TRACOE comfort - 04035324023349

Tube with 15 mm Connector and second additional inner cannula, clamp at the top
Tracoe medical GmbH
REF 888-105-11-1D
In Commercial Distribution

  • 04035324023349 ()

  • Lumen/Inner Diameter: 9.7 Millimeter
REF 888-105-11-1D

  • Tracheostomy tube, non-reinforced, non-customized, reusable

TRACOE comfort - 04035324023271

Tube with 15 mm Connector and second additional inner cannula, clamp at the top
Tracoe medical GmbH
REF 888-105-10-1D
In Commercial Distribution

  • 04035324023271 ()

  • Lumen/Inner Diameter: 8.7 Millimeter
REF 888-105-10-1D

  • Tracheostomy tube, non-reinforced, non-customized, reusable

TRACOE comfort - 04035324023202

Tube with 15 mm Connector and second additional inner cannula, clamp at the top
Tracoe medical GmbH
REF 888-105-09-1D
In Commercial Distribution

  • 04035324023202 ()

  • Lumen/Inner Diameter: 7.6 Millimeter
REF 888-105-09-1D

  • Tracheostomy tube, non-reinforced, non-customized, reusable

TRACOE comfort - 04035324023141

Tube with 15 mm Connector and second additional inner cannula, clamp at the top
Tracoe medical GmbH
REF 888-105-08-1D
In Commercial Distribution

  • 04035324023141 ()

  • Lumen/Inner Diameter: 6.8 Millimeter
REF 888-105-08-1D

  • Tracheostomy tube, non-reinforced, non-customized, reusable

TRACOE comfort - 04035324022953

Tube with 15 mm Connector and second additional inner cannula, clamp at the top
Tracoe medical GmbH
REF 888-105-05-1D
In Commercial Distribution

  • 04035324022953 ()

  • Lumen/Inner Diameter: 4.0 Millimeter
REF 888-105-05-1D

  • Tracheostomy tube, non-reinforced, non-customized, reusable

TRACOE® comfort - 04035324022885

Tube with 15 mm Connector and second additional inner cannula, clamp at the top
Tracoe medical GmbH
REF 888-105-04-1D
Not in Commercial Distribution

  • 04035324022885 ()

  • Lumen/Inner Diameter: 3.2 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use

TRACOE® comfort - 04035324022823

Tube with 15 mm Connector and second additional inner cannula, clamp at the top
Tracoe medical GmbH
REF 888-105-03-1D
Not in Commercial Distribution

  • 04035324022823 ()

  • Lumen/Inner Diameter: 2.6 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use

TRACOE comfort - 04035324023080

Tube with 15 mm Connector and second additional inner cannula, clamp at the top
Tracoe medical GmbH
REF 888-105-07-1D
In Commercial Distribution

  • 04035324023080 ()

  • Lumen/Inner Diameter: 5.8 Millimeter
REF 888-105-07-1D

  • Tracheostomy tube, non-reinforced, non-customized, reusable

TRACOE comfort - 04035324023028

Tube with 15 mm Connector and second additional inner cannula, clamp at the top
Tracoe medical GmbH
REF 888-105-06-1D
In Commercial Distribution

  • 04035324023028 ()

  • Lumen/Inner Diameter: 4.8 Millimeter
REF 888-105-06-1D

  • Tracheostomy tube, non-reinforced, non-customized, reusable

Power Dental USA - D9432321

HATCHET TGF 15L R-DOWN CUT, IN/OUT SHAPE, AT 2 O'CLOCK, for Duggan Institute
Power Dental U.S.A. Inc.
2321
In Commercial Distribution

  • D9432321 ()
2321

  • Dressing/utility forceps, scissors-like, reusable
  • Periodontal hoe

Power Dental USA - D9432320

HATCHET TGF 13L L-DOWN CUT, IN/OUT SHAPE, AT 2 O'CLOCK, for Duggan Institute
Power Dental U.S.A. Inc.
2320
In Commercial Distribution

  • D9432320 ()
2320

  • Dressing/utility forceps, scissors-like, reusable
  • Periodontal hoe

wtATTR-CM AcceleraTTR™ - 05415062388310

Software to identify heart failure patients who may be at risk of having wtATTR-CM
PFIZER INC.
CI4054279
In Commercial Distribution

  • 05415062388310 ()


  • Cardiovascular interpretive screening software

Novo Surgical - G586E7221780

anthony suction tube, 5 7/8" (14.9 cm), small: 2.0 mm lumen at tip
NOVO SURGICAL, INC.
E7221-78
In Commercial Distribution

  • G586E7221780 ()
E7221-78

  • Surgical/emergency suction cannula, non-illuminating, reusable

A. Titan Instruments - 00841685100988

Osteotome, offset, concave, 4.5 mm <5.0 mmDepth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
311.06
In Commercial Distribution

  • 00841685100988 ()


  • Dental osteotome

A. Titan Instruments - 00841685100926

Osteotome, straight, concave, 4.5 mm < 5.0 mmDepth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
310.06
In Commercial Distribution

  • 00841685100926 ()


  • Dental osteotome

A. Titan Instruments - 00841685100919

Osteotome, straight, concave, 4.0 mm <4.5 mmDepth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
310.05
In Commercial Distribution

  • 00841685100919 ()


  • Dental osteotome

A. Titan Instruments - 00841685100902

Osteotome, straight, concave, 3.5 mm < 4.0 mmDepth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
310.04
In Commercial Distribution

  • 00841685100902 ()


  • Dental osteotome

A. Titan Instruments - 00841685101084

Osteotome, angled, convex, 3.5 mm <4.0 mmDepth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
321.04
In Commercial Distribution

  • 00841685101084 ()


  • Dental osteotome

ASSI - 00841645104032

Deaver Retractor 25 x 300 mm 12 3/4" Without Serrations at Working End
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
ASSI.AG42526
In Commercial Distribution

  • 00841645104032 ()


  • Self-retaining surgical retractor, reusable

Novo Surgical Inc. - 00842331130670

anthony suction tube, 5 7/8" (14.9 cm), large: 3.0 mm lumen at tip
NOVO SURGICAL, INC.
E7221-77
In Commercial Distribution

  • 00842331130670 ()
E7221-77

  • Airway suction catheter

VMS Left Posterior Aiming Device (Re-Use) - 06009712290413

VMS Left Posterior Aiming Device (Re-Use): Used to score the femoral neck at 45°.
ELITE SURGICAL SUPPLIES (PTY) LTD
VMSAD14
In Commercial Distribution

  • 06009712290413 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

VMS Right Posterior Aiming Device (Re-Use) - 06009712290406

VMS Right Posterior Aiming Device (Re-Use): Used to score the femoral neck at 45°.
ELITE SURGICAL SUPPLIES (PTY) LTD
VMSAD13
In Commercial Distribution

  • 06009712290406 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

VMS Left Anterior Aiming Device (Re-Use) - 06009712290390

VMS Left Anterior Aiming Device (Re-Use): Used to score the femoral neck at 45°
ELITE SURGICAL SUPPLIES (PTY) LTD
VMSAD12
In Commercial Distribution

  • 06009712290390 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

VMS Right Anterior Aiming Device (Re-Use) - 06009712290383

VMS Right Anterior Aiming Device (Re-Use): Used to score the femoral neck at 45°.
ELITE SURGICAL SUPPLIES (PTY) LTD
VMSAD11
In Commercial Distribution

  • 06009712290383 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

SoLa Therapy Laser - 00854103007066

Infrared phototherapy device emitting up to 8W at 810/980nm, battery option, 10" display
LITECURE LLC
LTC-1510-SOLA
In Commercial Distribution

  • 00854103007066 ()


  • Musculoskeletal/physical therapy laser, professional

LightForce X - 00854103007295

Infrared phototherapy device emitting up to 10 W at 810/980 nm, 7" display
LITECURE LLC
LTC-1001-L-B6
In Commercial Distribution

  • 00854103007295 ()


  • Musculoskeletal/physical therapy laser, professional

Hayden Medical - 00840319720301

DeBakey Atraumatic Tissue Forceps, 2.0mm wide tips, 12" (30cm), NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-526NC
In Commercial Distribution

  • 00840319720301 ()
120-526NC

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable

Hayden Medical - 00840319720134

Gruenwald (Jansen) Dressing Forceps 7-1/2" (19cm), serrated, bayonet, NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-173NC
In Commercial Distribution

  • 00840319720134 ()
120-173NC

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable

Hayden Medical - 00840319720110

Gruenwald (Jansen) Dressing Forceps 6-1/4" (16cm), serrated, bayonet, NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-172NC
In Commercial Distribution

  • 00840319720110 ()
120-172NC

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable

Hayden Medical - 00840319739976

DeBakey Atraumatic Tissue Forceps, 2.0mm wide tips, 6" (15cm), NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-520NC
In Commercial Distribution

  • 00840319739976 ()
120-520NC

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable

Hayden Medical - 00840319739969

DeBakey Atraumatic Tissue Forceps, 1.5mm wide tips, 12" (30cm), NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-516NC
In Commercial Distribution

  • 00840319739969 ()
120-516NC

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
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