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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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HEATmarker® Time-Temperature Indicators: CT9 - 00852282007105

Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 9 months at 22.5°C.
Temptime Corporation
CT9
In Commercial Distribution

  • 00852282007105 ()


  • Medical product temperature point indicator, thermochemical

HEATmarker® Time-Temperature Indicators: CT6 - 00852282007099

Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 182 days at 22.5°C.
Temptime Corporation
CT6
In Commercial Distribution

  • 00852282007099 ()


  • Medical product temperature point indicator, thermochemical

HEATmarker® Time-Temperature Indicators: CT3 - 00852282007075

Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 91 days at 22.5°C.
Temptime Corporation
CT3
In Commercial Distribution

  • 00852282007075 ()


  • Medical product temperature point indicator, thermochemical

HEATmarker® Time-Temperature Indicators: CT36 - 00852282007136

Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 36 months at 22.5°C.
Temptime Corporation
CT36
In Commercial Distribution

  • 00852282007136 ()


  • Medical product temperature point indicator, thermochemical

HEATmarker® Time-Temperature Indicators: CT24 - 00852282007112

Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 24 months at 22.5°C.
Temptime Corporation
CT24
In Commercial Distribution

  • 00852282007112 ()


  • Medical product temperature point indicator, thermochemical

HEATmarker® Time-Temperature Indicators: CT4 - 00852282007082

Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 121 days at 22.5°C.
Temptime Corporation
CT4
In Commercial Distribution

  • 00852282007082 ()


  • Medical product temperature point indicator, thermochemical

HEATmarker® Time-Temperature Indicators: CT2 - 00852282007068

Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 60 days at 22.5°C.
Temptime Corporation
CT2
In Commercial Distribution

  • 00852282007068 ()


  • Medical product temperature point indicator, thermochemical

HEATmarker® Time-Temperature Indicators: F36 - 00852282007051

Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 36 months at 5°C.
Temptime Corporation
F36
In Commercial Distribution

  • 00852282007051 ()


  • Medical product temperature point indicator, thermochemical

HEATmarker® Time-Temperature Indicators: F24 - 00852282007044

Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 24 months at 5°C.
Temptime Corporation
F24
In Commercial Distribution

  • 00852282007044 ()


  • Medical product temperature point indicator, thermochemical

HEATmarker® Time-Temperature Indicators: F12 - 00852282007037

Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 12 months at 5°C.
Temptime Corporation
F12
In Commercial Distribution

  • 00852282007037 ()


  • Medical product temperature point indicator, thermochemical

HEATmarker® Time-Temperature Indicators: F9 - 00852282007020

Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 9 months at 5°C.
Temptime Corporation
F9
In Commercial Distribution

  • 00852282007020 ()


  • Medical product temperature point indicator, thermochemical

HEATmarker® Time-Temperature Indicators: F6 - 00852282007013

Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 182 days at 5°C.
Temptime Corporation
F6
In Commercial Distribution

  • 00852282007013 ()


  • Medical product temperature point indicator, thermochemical

HEATmarker® Time-Temperature Indicators: F3 - 00852282007006

Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 91 days at 5°C.
Temptime Corporation
F3
In Commercial Distribution

  • 00852282007006 ()


  • Medical product temperature point indicator, thermochemical

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

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

NA - 00724995156916

The IV Armboard without Pad with Velcro Straps supports arm at a comfortable angle.
STERIS CORPORATION
Arm Support
In Commercial Distribution

  • 00724995156916 ()
BF141

  • Arm procedure positioner, reusable

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 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

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

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

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

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

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

ELMED - 00842180163478

Offset Boxed Osteotome, Surgical Grade Autoclavable Stainless Steel -- (Additional Specs on file at Elmed)
ELMED INCORPORATED
23-7806-01001
In Commercial Distribution

  • 00842180163478 ()
23-7806-01001

  • Orthopaedic osteotome

ELMED - 00842180169722

Modified Blunt Hohmann Retractor, Standard, Blade Width at End: 11mm, Overall Length: 10.75" (27,3cm)
ELMED INCORPORATED
23-4550
In Commercial Distribution

  • 00842180169722 ()
23-4550

  • Hand-held surgical retractor, reusable

ELMED - 00842180191921

TEBBETTS AUFRICHT RETRACTOR, WITH STABILIZATION TEETH AT THE TIP, OVERALL LENGTH 4-3/4" (12CM)
ELMED INCORPORATED
ST151079
In Commercial Distribution

  • 00842180191921 ()
ST151079

  • Hand-held surgical retractor, reusable

ELMED - 00842180183100

TEBBETTS AUFRICHT RETRACTOR, WITH STABILIZATION TEETH AT THE TIP, OVERALL LENGTH 4-3/4" (12CM)
ELMED INCORPORATED
15-1079
In Commercial Distribution

  • 00842180183100 ()
15-1079

  • Hand-held surgical retractor, reusable

ELMED - 00842180197404

Offset Boxed Osteotome, Surgical Grade Autoclavable Stainless Steel -- (Additional Specs on file at Elmed)
ELMED INCORPORATED
ST23780601001
In Commercial Distribution

  • 00842180197404 ()
ST23780601001

  • Orthopaedic osteotome

ELMED - 00842180196773

Modified Blunt Hohmann Retractor, Standard, Blade Width at End: 11mm, Overall Length: 10.75" (27,3cm)
ELMED INCORPORATED
ST234550
In Commercial Distribution

  • 00842180196773 ()
ST234550

  • Hand-held surgical retractor, reusable

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

Ambler Surgical - 00190660127619

Ostium probe, 7 1/2'', double-ended, curved, one end at 90 degrees, hexagonal handle
AMBLER SURGICAL CORP.
Ostium probe
In Commercial Distribution

  • 00190660127619 ()
44-947

  • Fistula probe

Rumex - 00840159908945

Corneal Forceps, 0.12 mm, 2x2 Teeth set at 45°, With Tying Platforms, Stainless Steel
RUMEX INTERNATIONAL CORP.
4-425S
In Commercial Distribution

  • 00840159908945 ()
4-425S

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

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 - 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

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
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