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

  • 00842180197404 ()
ST23780601001

  • Orthopaedic osteotome
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