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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VIP 2000 Upgrade 150 mL Basin Kit
ABBOTT MOLECULAR INC.
02J11-041
In Commercial Distribution

  • 00884999046146 ()
02J11-041

  • Tissue processor IVD, automated/semi-automated
SUNGLASSES-SPMIRAMAR C02 SLATEBLUE/GLD 54-18 135C
L'Amy, Incorporated
SPMIRAMAR02
In Commercial Distribution

  • 00882851379173 ()


  • Tinted non-prescription spectacles
SUNGLASSES-TYATP915 C03 AUVERGINE/RSE GLD 52-19135C
L'Amy, Incorporated
TYATP91503
In Commercial Distribution

  • 00730638385872 ()


  • Tinted non-prescription spectacles
10 Gld Foil Chisel Wedelstaedt 10.5-15-3
HU-FRIEDY MFG. CO., LLC
GF10
Not in Commercial Distribution

  • 10889950049270 ()
GF10

  • Periodontal file/rasp, manual
PKG,JBR ENH SEL 300,GLD
Gn Hearing A/S
22982770
In Commercial Distribution

  • 05708296320745 ()


  • Air-conduction hearing aid, receiver-in-canal
PKG,JBR ENH SEL 200,GLD
Gn Hearing A/S
22900370
In Commercial Distribution

  • 05708296313938 ()


  • Air-conduction hearing aid, receiver-in-canal
SS GLD 017X022 14IN PKG 10
DENTSPLY SIRONA ORTHODONTICS INC.
03-722-68
Not in Commercial Distribution

  • D80703722680 ()
  • D80703722681 ()
03-722-68

  • Orthodontic archwire
SS GLD 016X022 14IN PKG 10
DENTSPLY SIRONA ORTHODONTICS INC.
03-622-68
Not in Commercial Distribution

  • D80703622680 ()
  • D80703622681 ()
03-622-68

  • Orthodontic archwire
SS GLD 016X016 14IN PKG 10
DENTSPLY SIRONA ORTHODONTICS INC.
03-616-68
Not in Commercial Distribution

  • D80703616680 ()
  • D80703616681 ()
03-616-68

  • Orthodontic archwire
SS GLD IDEAL® 16X16 LWR
DENTSPLY SIRONA ORTHODONTICS INC.
03-616-66
Not in Commercial Distribution

  • D80703616660 ()
  • D80703616661 ()
03-616-66

  • Orthodontic archwire
SS GLD IDEAL® 16X16 UPR
DENTSPLY SIRONA ORTHODONTICS INC.
03-616-65
Not in Commercial Distribution

  • D80703616650 ()
  • D80703616651 ()
03-616-65

  • Orthodontic archwire
SS GLD ACCU-FORM® 16X16 LWR
DENTSPLY SIRONA ORTHODONTICS INC.
03-616-64
Not in Commercial Distribution

  • D80703616640 ()
  • D80703616641 ()
03-616-64

  • Orthodontic archwire
SS GLD ACCU-FORM® 16X16 UPR
DENTSPLY SIRONA ORTHODONTICS INC.
03-616-63
Not in Commercial Distribution

  • D80703616630 ()
  • D80703616631 ()
03-616-63

  • Orthodontic archwire
SS GLD 215X028 14IN PKG 10
DENTSPLY SIRONA ORTHODONTICS INC.
03-528-68
Not in Commercial Distribution

  • D80703528680 ()
  • D80703528681 ()
03-528-68

  • Orthodontic archwire
SS GLD IDEAL® 20X20 UPR
DENTSPLY SIRONA ORTHODONTICS INC.
03-220-65
Not in Commercial Distribution

  • D80703220650 ()
  • D80703220651 ()
03-220-65

  • Orthodontic archwire
SS GLD IDEAL® 175X175 LWR
DENTSPLY SIRONA ORTHODONTICS INC.
03-175-66
Not in Commercial Distribution

  • D80703175660 ()
  • D80703175661 ()
03-175-66

  • Orthodontic archwire
SS GLD IDEAL® 175X175 UPR
DENTSPLY SIRONA ORTHODONTICS INC.
03-175-65
Not in Commercial Distribution

  • D80703175650 ()
  • D80703175651 ()
03-175-65

  • Orthodontic archwire
SS GLD 021X025 14IN PKG 10
DENTSPLY SIRONA ORTHODONTICS INC.
03-125-68
Not in Commercial Distribution

  • D80703125680 ()
  • D80703125681 ()
03-125-68

  • Orthodontic archwire
SS GLD IDEAL® 020RD LWR
DENTSPLY SIRONA ORTHODONTICS INC.
03-020-66
Not in Commercial Distribution

  • D80703020660 ()
  • D80703020661 ()
03-020-66

  • Orthodontic archwire
SS GLD ACCU-FORM® 020RD LWR
DENTSPLY SIRONA ORTHODONTICS INC.
03-020-64
Not in Commercial Distribution

  • D80703020640 ()
  • D80703020641 ()
03-020-64

  • Orthodontic archwire
SS GLD ACCU-FORM® 020RD UPR
DENTSPLY SIRONA ORTHODONTICS INC.
03-020-63
Not in Commercial Distribution

  • D80703020630 ()
  • D80703020631 ()
03-020-63

  • Orthodontic archwire
SS GLD 018RD 14IN PKG 50
DENTSPLY SIRONA ORTHODONTICS INC.
03-018-68
Not in Commercial Distribution

  • D80703018680 ()
  • D80703018681 ()
03-018-68

  • Orthodontic archwire
TUBE MICRO W/MICROGARD SST GLD
BECTON, DICKINSON AND COMPANY
365967
In Commercial Distribution

  • 30382903659679 ()
  • 00382903659678 ()
  • 50382903659673 ()
365967

  • Non-evacuated blood collection tube IVD, clot activator/separator
Aquatec Ocean Comfort soft backrest (Ergo VIP Models)
INVACARE CORPORATION
AP1603606
In Commercial Distribution

  • 04028698132847 ()
AP1603606

  • Shower seat, non-powered
VIP Film Probe Cover w/ Elastic bands 15x61cm
EXACT MEDICAL MANUFACTURING, INC.
E6320
Not in Commercial Distribution

  • 00816953026604 ()
  • 00816953025898 ()
  • 00816953026611 ()


  • Medical equipment/instrument drape, single-use
8cm VIP film Tube 1250 meters per roll
EXACT MEDICAL MANUFACTURING, INC.
E6512N
Not in Commercial Distribution

  • 00816953029599 ()
  • 00816953029582 ()


  • Medical equipment/instrument drape, single-use
Probe Cover, VIP film, Gel, El.b, Cardb. 15x61cm
EXACT MEDICAL MANUFACTURING, INC.
E6446A
In Commercial Distribution

  • 16975085704352 ()
  • 06975085704355 ()
  • 26975085704359 ()
E6446A

  • Body-surface ultrasound imaging transducer cover
SUNGLASSES -SPWHITECAP C02 MATBROWN/GLD 55-17 137C
L'Amy, Incorporated
SPWHITECAP02
In Commercial Distribution

  • 00882851379326 ()


  • Tinted non-prescription spectacles
SUNGLASSES -NMMAURITIUS C01 BERRY/ROSE GLD 54-19140C
L'Amy, Incorporated
NMMAURITIUS01
In Commercial Distribution

  • 00730638423512 ()


  • Tinted non-prescription spectacles
SUNGLASSES-TYATP917 C02 TRANS ROSE/LT GLD 52-17135C
L'Amy, Incorporated
TYATP91702
In Commercial Distribution

  • 00730638389818 ()


  • Tinted non-prescription spectacles
SUNGLASSES-TYATP915 C02 BLUSH MRBL/LT GLD 52-19135C
L'Amy, Incorporated
TYATP91502
In Commercial Distribution

  • 00730638385865 ()


  • Tinted non-prescription spectacles
SUNGLASSES -SPCROSSHAVEN C01 BLK/ ROSE GLD 54-15135C
L'Amy, Incorporated
SPCROSSHAVEN01
In Commercial Distribution

  • 00730638373916 ()


  • Tinted non-prescription spectacles
SUNGLASSES-TYATP922 C02 CRYSTAL/ROSE GLD 52-18 135C
L'Amy, Incorporated
TYATP92202
In Commercial Distribution

  • 00730638402630 ()


  • Tinted non-prescription spectacles
FB SLD CLFR 25X75X1 GLD 144/PK
FISHER SCIENTIFIC COMPANY L.L.C.
9951GL-600621
In Commercial Distribution

  • 20613647011472 ()
  • 00613647011478 ()
  • 30613647011479 ()
  • 10613647011475 ()
22037080

  • General specimen microscopy slide IVD, single-use
SS GLD 020 RD 14IN PKG 50
DENTSPLY SIRONA ORTHODONTICS INC.
03-020-68
Not in Commercial Distribution

  • D80703020680 ()
  • D80703020681 ()
03-020-68

  • Orthodontic archwire
SS GLD IDEAL® 020 RD UPR
DENTSPLY SIRONA ORTHODONTICS INC.
03-020-65
Not in Commercial Distribution

  • D80703020650 ()
  • D80703020651 ()
03-020-65

  • Orthodontic archwire
SS GLD 016 RD 14IN PKG 50
DENTSPLY SIRONA ORTHODONTICS INC.
03-016-68
Not in Commercial Distribution

  • D80703016680 ()
  • D80703016681 ()
03-016-68

  • Orthodontic wire
SS GLD 014 RD 14IN PKG 50
DENTSPLY SIRONA ORTHODONTICS INC.
03-014-68
Not in Commercial Distribution

  • D80703014680 ()
  • D80703014681 ()
03-014-68

  • Orthodontic wire
TUBE MICRO W/MICROGARD SST GLD/AMB
BECTON, DICKINSON AND COMPANY
365978
In Commercial Distribution

  • 30382903659785 ()
  • 00382903659784 ()
  • 50382903659789 ()
365978

  • Non-evacuated blood collection tube IVD, clot activator/separator
CONTROL 306-03POR PORC HMS BLU/GLD 10BX
MEDTRONIC, INC.
306-03POR
In Commercial Distribution

  • 00763000014773 ()
  • 20763000014777 ()


  • Coagulation timer IVD
CONTROL 306-03POR PORC HMS BLU/GLD 10BX
MEDTRONIC, INC.
306-03POR
In Commercial Distribution

  • 20613994923305 ()
  • 00613994923301 ()


  • Coagulation timer IVD
MVHS VASC PWR GLD DRG CHG KIT
Cardinal Health 200, LLC
03-5472H
In Commercial Distribution

  • 50197106164417 ()
  • 10197106164419 ()
03-5472H

  • General surgical procedure kit, medicated
Aquatec Ocean Front and back anti-tipper (Ergo VIP Models)
INVACARE CORPORATION
AP1603992
In Commercial Distribution

  • 04028698132854 ()
AP1603992

  • Shower seat, non-powered
BR HDS EF FL VIP NP 3PK +1 HD
TARGET CORPORATION
2E6
Not in Commercial Distribution

  • 00071031776523 ()


  • Basic electric toothbrush
BR HDS EF II VIP NP 3PK +1 HD
TARGET CORPORATION
2A9
Not in Commercial Distribution

  • 00071031775526 ()


  • Basic electric toothbrush
Kit VIP Film Probe Cover w/ Gel & Elasticbands 15x244cm
EXACT MEDICAL MANUFACTURING, INC.
E6435
Not in Commercial Distribution

  • 00816953029049 ()
  • 00816953029032 ()
  • 00816953029056 ()


  • Medical equipment/instrument drape, single-use
Kit VIP Film Probe Cover w/ Gel & Elasticbands 15x122cm
EXACT MEDICAL MANUFACTURING, INC.
E6432
Not in Commercial Distribution

  • 00816953028981 ()
  • 00816953028974 ()
  • 00816953028998 ()


  • Medical equipment/instrument drape, single-use
Kit VIP Film Probe Cover w/ Elasticbands & Gel 15x61cm
EXACT MEDICAL MANUFACTURING, INC.
E6428
Not in Commercial Distribution

  • 10816953028896 ()
  • 00816953028899 ()
  • 00816953028905 ()


  • Medical equipment/instrument drape, single-use
Probe Cover , VIP film , Gel and Elastic Bands 13x122cm
EXACT MEDICAL MANUFACTURING, INC.
MM2001
In Commercial Distribution

  • 16975424191324 ()
  • 06975424191327 ()
  • 26975424191321 ()
MM2001

  • Body-surface ultrasound imaging transducer cover
Probe Cover , VIP film , Gel and Elastic Bands 13x61cm
EXACT MEDICAL MANUFACTURING, INC.
MM2000
In Commercial Distribution

  • 16975424191317 ()
  • 06975424191310 ()
  • 26975424191314 ()
MM2000

  • Body-surface ultrasound imaging transducer cover
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