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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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Half Apron with Ties - 802T -24" x 20" -0.5mm Regular Lead (RL)
Shielding International Inc.
802TRL
In Commercial Distribution

  • G031802TRL0 ()


  • Radiation shielding apron
003 RETAINING RING WITH O-RING INSERTED
OCO BIOMEDICAL INC
003 RETAINING RING WITH O-RING INSERTED
In Commercial Distribution

  • D785003RRWO0 ()
003 RR W/O-RING

  • Denture clasp, polymer, preformed
002 CAP WITH O-RING INSERTED (002BN900)
OCO BIOMEDICAL INC
002 CAP W/O-RING (002BN900)
In Commercial Distribution

  • D785002CAPWOBN0 ()
002 CAP W/O-RING (002BN900)

  • Denture clasp, polymer, preformed
002 CAP WITH 002 BLK O-RING INSERTED
OCO BIOMEDICAL INC
002 CAP WITH 002 BLK O-RING INSERTED
In Commercial Distribution

  • D785002CAPWO0 ()
002 CAP W/O-RING

  • Denture clasp, polymer, preformed
CAST.REP. POST WITH TITANIUM BASE, PRE-KOH D.4.25 MM
SWEDEN & MARTINA SPA
A-UCTR-425-EX
In Commercial Distribution

  • D7700830803 ()
A-UCTR-425-EX

  • Dental implant suprastructure, permanent, preformed
CAST.REP. POST WITH TITANIUM BASE, PRE-KOH D.3.80 MM
SWEDEN & MARTINA SPA
A-UCTR-380-EX
In Commercial Distribution

  • D7700830773 ()
A-UCTR-380-EX

  • Dental implant suprastructure, permanent, preformed
TORQUE WRENCH WITH LEVER CONTROL
SWEDEN & MARTINA SPA
TWL
In Commercial Distribution

  • D7701224923 ()
TWL

  • Dental implant/prosthesis surgical procedure kit
PARALLELISM PIN WITH DEPTH LINES, D.2,00 MM SMALL
SWEDEN & MARTINA SPA
PPTS-2-28
In Commercial Distribution

  • D7701224733 ()
PPTS-2-28

  • Dental implant/prosthesis surgical procedure kit
PARALLELISM PIN WITH DEPTH LINES, D.2,00 MM LARGE
SWEDEN & MARTINA SPA
PPTL-2-28
In Commercial Distribution

  • D7701224693 ()
PPTL-2-28

  • Dental implant/prosthesis surgical procedure kit
CAST.REP. POST WITH TITANIUM BASE, PRE-KOH D.5,00 MM
SWEDEN & MARTINA SPA
A-UCTR-500-EX
In Commercial Distribution

  • D7701061123 ()
A-UCTR-500-EX

  • Dental implant suprastructure, permanent, preformed
CAST.REP. POST WITH TITANIUM BASE, PRE-KOH D.3.30 MM
SWEDEN & MARTINA SPA
A-UCTR-330-EX
In Commercial Distribution

  • D7701061113 ()
A-UCTR-330-EX

  • Dental implant suprastructure, permanent, preformed
Matrix sleeve with fixing screw 1.8 mm Ø 2 Pieces each 4 Pieces
bredent GmbH & Co. KG
43007298
In Commercial Distribution

  • EBRE430072989 ()
  • EBRE430072980 ()
  • EBRE430072988 ()

  • Length: 5.3 Millimeter
  • Outer Diameter: 3.2 Millimeter
43007298

  • Screw endosteal dental implant, two-piece
Matrix sleeve with fixing screw 1.4 mm Ø 2 Pieces each 4 Pieces
bredent GmbH & Co. KG
43007297
In Commercial Distribution

  • EBRE430072979 ()
  • EBRE430072970 ()
  • EBRE430072978 ()

  • Length: 5.3 Millimeter
  • Outer Diameter: 2.8 Millimeter
43007297

  • Screw endosteal dental implant, two-piece
Matrix sleeve with fixing screw 1.0 mm Ø 2 Pieces each 4 Pieces
bredent GmbH & Co. KG
43007296
In Commercial Distribution

  • EBRE430072969 ()
  • EBRE430072960 ()
  • EBRE430072968 ()

  • Length: 5.3 Millimeter
  • Outer Diameter: 2.8 Millimeter
43007296

  • Screw endosteal dental implant, two-piece
MectaCem-X HV with Gentamicin is a low viscosity antibiotic-loaded polymethylmethacrylate bone cements. It is composed by two components (40g powder and 14,7g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use. MectaCem-X HV with Gentamicin is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
TECRES SPA
65.01.111US
In Commercial Distribution

  • 08031497002163 ()


  • Orthopaedic cement, antimicrobial
MectaCem-X LV with Gentamicin is a low viscosity antibiotic-loaded polymethylmethacrylate bone cements. It is composed by two components (40g powder and 14,7g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use. MectaCem-X LV with Gentamicin is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
TECRES SPA
65.01.113US
In Commercial Distribution

  • 08031497002149 ()


  • Orthopaedic cement, antimicrobial
Fix mount drencher shower head, brushed nickel
WATER PIK, INC.
XED-639E
In Commercial Distribution

  • 00073950283649 ()
XED-639E

  • External manual massager, home-use
Fix mount drencher shower head, brushed nickel
WATER PIK, INC.
XED-639E
In Commercial Distribution

  • 00073950279659 ()
XED-639E

  • External manual massager, home-use
Fix mount drencher shower head, brushed nickel
WATER PIK, INC.
XED-639
Not in Commercial Distribution

  • 00073950273725 ()
XED-639

  • External manual massager, home-use
Fix mount drencher shower head, chrome
WATER PIK, INC.
XED-633
Not in Commercial Distribution

  • 00073950273718 ()
XED-633

  • External manual massager, home-use
Hand held shower head, brushed nickel
WATER PIK, INC.
VOT-669E
Not in Commercial Distribution

  • 00073950272407 ()
VOT-669E

  • External manual massager, home-use
Hand held shower head, chrome
WATER PIK, INC.
VOT-663E
Not in Commercial Distribution

  • 00073950272322 ()
VOT-663E

  • External manual massager, home-use
Fix mount drencher shower head, brushed nickel
WATER PIK, INC.
XEM-639E
In Commercial Distribution

  • 00073950272209 ()
XEM-639E

  • External manual massager, home-use
Fix mount drencher shower head, chrome
WATER PIK, INC.
XMT-633E
Not in Commercial Distribution

  • 00073950259033 ()
XMT-633E

  • External manual massager, home-use
Hand held shower head, chrome
WATER PIK, INC.
LBT-563M
Not in Commercial Distribution

  • 00073950254137 ()
LBT-563M

  • External manual massager, home-use
Fix mount drencher shower head, brushed nickel
WATER PIK, INC.
XMD-639E
Not in Commercial Distribution

  • 00073950247979 ()
XMD-639E

  • External manual massager, home-use
Fix mount drencher shower head, brushed nickel
WATER PIK, INC.
XMT-639
Not in Commercial Distribution

  • 00073950236119 ()
XMT-639

  • External manual massager, home-use
This device is a plastic disconnect cap for peritoneal dialysis and contains povidone-iodine intended to protect the female Luer connector of the Baxter transfer set.
BAXTER HEALTHCARE CORPORATION
5C4466P
In Commercial Distribution

  • 50085412007699 ()
  • 00085412007694 ()
5C4466P

  • Peritoneal dialysis system tubing set
TWINKLE PRO EMBRYO TRANS Embryo Transfer Catheter with Stylet
ALLWIN MEDICAL DEVICES, INC.
TWINKLE PRO EMBRYO TRANS Embryo Transfer Catheter with Stylet
In Commercial Distribution

  • 10819374021750 ()
  • 00819374021753 ()
TPEB-ETC-STY

  • Assisted reproduction transfer catheter/set
110 in. (280 cm) Microset with Filter - yellow stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A100-163XSFL
Not in Commercial Distribution

  • 10818666020280 ()
  • 00818666020283 ()


  • Electric infusion pump administration set, single-use
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