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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MOD 2200 .125OD I/E,4MMOD MPT
HANS RUDOLPH, INC.
2200
Not in Commercial Distribution

  • 00874750007967 ()
P0355

  • Non-rebreathing valve, reusable
INSERTER 1352237 E/Z LOAD T TUBE
MEDTRONIC XOMED, INC.
1352237
In Commercial Distribution

  • 00681490038263 ()


  • Tympanostomy tube inserter, reusable
Special 5.5 X 8, Green, 5 E
HU-FRIEDY MFG. CO., LLC
IM59E5
In Commercial Distribution

  • 10889950141172 ()


  • Device sterilization/disinfection container, reusable
COVERALL, E/W&A, COLLAR;WHITE, XXL
A PLUS INTERNATIONAL INC.
1
Not in Commercial Distribution

  • 80683534080050 ()
  • 00683534080054 ()
68-601W-Y

  • Patient gown, single-use
COVERALL, E/W&A, COLLAR;WHITE, S
A PLUS INTERNATIONAL INC.
1
Not in Commercial Distribution

  • 80683534080036 ()
  • 00683534080030 ()
68-601W-S

  • Patient gown, single-use
Abutment Healing PKC Pre E/H Ø4
SOUTHERN IMPLANTS (PTY) LTD
HA-PKC4-EX-40
In Commercial Distribution

  • 06009544049876 ()


  • Dental implant suprastructure, temporary, preformed, single-use
Abutment Healing PKC Pre E/H Ø3.25
SOUTHERN IMPLANTS (PTY) LTD
HA-PKC4-EX-34
In Commercial Distribution

  • 06009544049869 ()


  • Dental implant suprastructure, temporary, preformed, single-use
Abutment Healing PKC Can E/H Ø4
SOUTHERN IMPLANTS (PTY) LTD
HA-PKC3-EX-40
In Commercial Distribution

  • 06009544049838 ()


  • Dental implant suprastructure, temporary, preformed, single-use
Abutment Healing PKC Can E/H Ø3.25
SOUTHERN IMPLANTS (PTY) LTD
HA-PKC3-EX-34
In Commercial Distribution

  • 06009544049821 ()


  • Dental implant suprastructure, temporary, preformed, single-use
Abutment Healing PKC Lat E/H Ø3.25
SOUTHERN IMPLANTS (PTY) LTD
HA-PKC2-EX-34
In Commercial Distribution

  • 06009544049791 ()


  • Dental implant suprastructure, temporary, preformed, single-use
Abutment Healing PKC Lat E/H Ø4
SOUTHERN IMPLANTS (PTY) LTD
HA-PKC2-EX-40
In Commercial Distribution

  • 06009544049784 ()


  • Dental implant suprastructure, temporary, preformed, single-use
Abutment Healing PKC Lat E/H Ø3
SOUTHERN IMPLANTS (PTY) LTD
HA-PKC2-EX-30
In Commercial Distribution

  • 06009544049777 ()


  • Dental implant suprastructure, temporary, preformed, single-use
Abutment Healing PKC Cen E/H Ø4
SOUTHERN IMPLANTS (PTY) LTD
HA-PKC1-EX-40
In Commercial Distribution

  • 06009544049739 ()


  • Dental implant suprastructure, temporary, preformed, single-use
Abutment Healing PKC Cen E/H Ø3.25
SOUTHERN IMPLANTS (PTY) LTD
HA-PKC1-EX-34
In Commercial Distribution

  • 06009544049722 ()


  • Dental implant suprastructure, temporary, preformed, single-use
Abutment Healing PKC Cen E/H Ø3
SOUTHERN IMPLANTS (PTY) LTD
HA-PKC1-EX-30
In Commercial Distribution

  • 06009544049715 ()


  • Dental implant suprastructure, temporary, preformed, single-use
BioStep LP, Size 30, Right, Rate E
Alps South, LLC
BSLP-30RE
In Commercial Distribution

  • 00713980024071 ()


  • Mechanical-resistance external ankle-foot prosthesis
BioStep LP, Size 30, Left, Rate E
Alps South, LLC
BSLP-30LE
In Commercial Distribution

  • 00713980023913 ()


  • Mechanical-resistance external ankle-foot prosthesis
BioStep LP, Size 29, Right, Rate E
Alps South, LLC
BSLP-29RE
In Commercial Distribution

  • 00713980023753 ()


  • Mechanical-resistance external ankle-foot prosthesis
BioStep LP, Size 29, Left, Rate E
Alps South, LLC
BSLP-29LE
In Commercial Distribution

  • 00713980023593 ()


  • Mechanical-resistance external ankle-foot prosthesis
BioStep LP, Size 28, Right, Rate E
Alps South, LLC
BSLP-28RE
In Commercial Distribution

  • 00713980023432 ()


  • Mechanical-resistance external ankle-foot prosthesis
BioStep LP, Size 27, Right, Rate E
Alps South, LLC
BSLP-27RE
In Commercial Distribution

  • 00713980023111 ()


  • Mechanical-resistance external ankle-foot prosthesis
BioStep LP, Size 27, Left, Rate E
Alps South, LLC
BSLP-27LE
In Commercial Distribution

  • 00713980022954 ()


  • Mechanical-resistance external ankle-foot prosthesis
BioStep LP, Size 26, Right, Rate E
Alps South, LLC
BSLP-26RE
In Commercial Distribution

  • 00713980022794 ()


  • Mechanical-resistance external ankle-foot prosthesis
BioStep LP, Size 26, Left, Rate E
Alps South, LLC
BSLP-26LE
In Commercial Distribution

  • 00713980022633 ()


  • Mechanical-resistance external ankle-foot prosthesis
BioStep LP, Size 25, Right, Rate E
Alps South, LLC
BSLP-25RE
In Commercial Distribution

  • 00713980022473 ()


  • Mechanical-resistance external ankle-foot prosthesis
BioStep LP, Size 25, Left, Rate E
Alps South, LLC
BSLP-25LE
In Commercial Distribution

  • 00713980022312 ()


  • Mechanical-resistance external ankle-foot prosthesis
BioStep LP, Size 24, Right, Rate E
Alps South, LLC
BSLP-24RE
In Commercial Distribution

  • 00713980022237 ()


  • Mechanical-resistance external ankle-foot prosthesis
BioStep LP, Size 24, Left, Rate E
Alps South, LLC
BSLP-24LE
In Commercial Distribution

  • 00713980022152 ()


  • Mechanical-resistance external ankle-foot prosthesis
BioStep LP, Size 23, Right, Rate E
Alps South, LLC
BSLP-23RE
In Commercial Distribution

  • 00713980022077 ()


  • Mechanical-resistance external ankle-foot prosthesis
BioStep LP, Size 23, Left, Rate E
Alps South, LLC
BSLP-23LE
In Commercial Distribution

  • 00713980021995 ()


  • Mechanical-resistance external ankle-foot prosthesis
BioStep LP, Size 22, Right, Rate E
Alps South, LLC
BSLP-22RE
In Commercial Distribution

  • 00713980021919 ()


  • Mechanical-resistance external ankle-foot prosthesis
BioStep LP, Size 22, Left, Rate E
Alps South, LLC
BSLP-22LE
In Commercial Distribution

  • 00713980021834 ()


  • Mechanical-resistance external ankle-foot prosthesis
BioStep LP, Size 28, Left, Rate E
Alps South, LLC
BSLP-28LE
In Commercial Distribution

  • 00713980023272 ()


  • Mechanical-resistance external ankle-foot prosthesis
CUSTOM PACK 3G08R 2PK E ACCSS PK
MEDTRONIC, INC.
3G08R
In Commercial Distribution

  • 20721902861875 ()
  • 00721902861871 ()


  • Cardiopulmonary bypass system blood tubing set
KIT LABOR & DELIVERY D&C/D&E
MEDLINE INDUSTRIES, INC.
DYKMBNDL31A
In Commercial Distribution

  • 40195327618880 ()
  • 10195327618889 ()
DYKMBNDL31A

  • General surgical procedure kit, non-medicated, single-use
KIT LABOR & DELIVERY D&C/D&E
MEDLINE INDUSTRIES, INC.
DYKMBNDL31B
In Commercial Distribution

  • 40195327660032 ()
  • 10195327660031 ()
DYKMBNDL31B

  • General surgical procedure kit, non-medicated, single-use
SMARTFrame XG TwistPoint Kit w/ HC - E
Clearpoint Neuro, Inc.
CP-NGS-11-HC-TP32-E
Not in Commercial Distribution

  • 00850359007072 ()
CP-NGS-11-HC-TP32-E

  • Neurological stereotactic surgery system
HA EJY E-PA E22 E 220 DEBLU
Widex A/S
ENJOY E-PA 220
In Commercial Distribution

  • 05706069839944 ()
10989662

  • Air-conduction hearing aid, receiver-in-canal
HA EJY E-PA E22 E 220 ATBG
Widex A/S
ENJOY E-PA 220
In Commercial Distribution

  • 05706069839937 ()
10989661

  • Air-conduction hearing aid, receiver-in-canal
HA EJY E-PA E22 E 220 TMGR
Widex A/S
ENJOY E-PA 220
In Commercial Distribution

  • 05706069839920 ()
10989660

  • Air-conduction hearing aid, receiver-in-canal
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