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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DB BRACKETS 18 CEN U
LEONE SPA
F2081-21
In Commercial Distribution

  • 08033707038122 ()
F2081-21

  • Orthodontic bracket, metal
DB BRACKETS 22 LAT U
LEONE SPA
F2022-931
In Commercial Distribution

  • 08033707037101 ()
F2022-931

  • Orthodontic bracket, metal
DB BRACKETS 22 LAT U
LEONE SPA
F2022-31
In Commercial Distribution

  • 08033707037088 ()
F2022-31

  • Orthodontic bracket, metal
DB BRACKETS 22 CEN U
LEONE SPA
F2021-921
In Commercial Distribution

  • 08033707037019 ()
F2021-921

  • Orthodontic bracket, metal
DB BRACKETS 22 CEN U
LEONE SPA
F2021-21
In Commercial Distribution

  • 08033707036982 ()
F2021-21

  • Orthodontic bracket, metal
ORMESH PAD MOLAR U/L
ORMCO CORPORATION
300-0038
In Commercial Distribution

  • 00889989086409 ()


  • Orthodontic bracket, metal
OHDII FHD QL AIR03 U
MAQUET SAS
ARD568803952
In Commercial Distribution

  • 03700712415976 ()


  • Surgical video camera
.022 Kit U/L 5x5
ORTHO ORGANIZERS, INC.
702-949Q
Not in Commercial Distribution

  • 00190707057169 ()


  • Orthodontic bracket, metal
VEGA PERMANENT ABUTMENT WRENCH [U]
SOADCO, S.L.
18 07 31
In Commercial Distribution

  • 08435451605269 ()
18 07 31

  • Surgical screwdriver, reusable
EC 12° CASTABLE ABUTMENT [U]
SOADCO, S.L.
10 12 14 U
In Commercial Distribution

  • 08435451602398 ()
10 12 14 U

  • Dental implant suprastructure kit
EC 4° CASTABLE ABUTMENT [U]
SOADCO, S.L.
10 12 06 U
In Commercial Distribution

  • 08435451602336 ()
10 12 06 U

  • Dental implant suprastructure kit
EC 4° CASTABLE ABUTMENT [U]
SOADCO, S.L.
10 12 05 U
In Commercial Distribution

  • 08435451602312 ()
10 12 05 U

  • Dental implant suprastructure kit
Non-Rebreather, Ped, 2-Valve, U. Conn.
MEDSOURCE INTERNATIONAL LLC
MS-25057-U
In Commercial Distribution

  • 00840155400078 ()
  • 00840155400061 ()
Not Applicable

  • Non-rebreathing oxygen face mask
Rebreather, Infant, Under-Lip, U. Conn.
MEDSOURCE INTERNATIONAL LLC
MS-25054-U
In Commercial Distribution

  • 00840155400016 ()
  • 00840155400009 ()
Not Applicable

  • Rebreathing oxygen face mask
VEGA PERMANENT ABUTMENT WRENCH [U]
SOADCO, S.L.
18 07 31
In Commercial Distribution

  • 08435451645876 ()
18 07 31

  • Surgical screwdriver, reusable
EC 12° CASTABLE ABUTMENT [U]
SOADCO, S.L.
10 12 14 U
In Commercial Distribution

  • 08435451645111 ()
10 12 14 U

  • Dental implant suprastructure kit
SK2 Ø4.7MM CASTABLE ABUTMENT [U]
SOADCO, S.L.
G-9020
In Commercial Distribution

  • 08435451611918 ()
G-9020

  • Dental implant suprastructure kit
VEGA PERMANENT ABUTMENT WRENCH [U]
SOADCO, S.L.
18 07 31
In Commercial Distribution

  • 08435451695635 ()
18 07 31

  • Surgical screwdriver, reusable
SK2 Ø4.7MM CASTABLE ABUTMENT [U]
SOADCO, S.L.
G-9020
In Commercial Distribution

  • 08435451660459 ()
G-9020

  • Dental implant suprastructure kit
U of MN Retractor (Economy)
Zoll-Dental
RET-UofMN
In Commercial Distribution

  • 00840105211563 ()


  • Hand-held dental retractor
Retractor, U of MN Caewood
Zoll-Dental
Z-5564
In Commercial Distribution

  • 00840105219293 ()


  • Hand-held dental retractor
U/L 5-5 0.56mm (0.022")
TP ORTHODONTICS INC
290-600
In Commercial Distribution

  • 00192029021323 ()


  • Orthodontic bracket, metal
SE PROBE U OF MICH
NORDENT MANUFACTURING INC
PUM
In Commercial Distribution

  • 00840018606487 ()


  • Periodontal probe, reusable
CHEST U & BAR DRAPE PACK
O&M HALYARD, INC.
29248
In Commercial Distribution

  • 30680651292484 ()
  • 10680651292480 ()


  • General surgical procedure kit, non-medicated, single-use
SEW 018/U & L3 NARROW
Gc Orthodontics America Inc.
26-1730-0012
In Commercial Distribution

  • D78826173000120 ()
  • D78826173000121 ()
26-1730-0012

  • Orthodontic bracket, metal
EXM MBT 022 U 2-2
Gc Orthodontics America Inc.
20-2F00-0020
In Commercial Distribution

  • D788202F0000201 ()
20-2F00-0020

  • Orthodontic bracket, metal
EXL SB 018 U 5-5
Gc Orthodontics America Inc.
17-1C00-0010
In Commercial Distribution

  • D788171C0000100 ()
  • D788171C0000101 ()
17-1C00-0010

  • Orthodontic bracket, metal
Glase Pro U Laser System
Candela Corporation
9914-CH-9030
In Commercial Distribution

  • 00817495024646 ()


  • Dermatological solid-state laser system
GYAG Pro U Laser System
Candela Corporation
9914-CH-9020
In Commercial Distribution

  • 00817495024639 ()
9914-CH-9020

  • Patient surgical drape, single-use
GYAG Pro U Laser System
Candela Corporation
9914-CH-9020
Not in Commercial Distribution

  • 00817495023656 ()


  • Dermatological solid-state laser system
Glase Pro U Laser System
Candela Corporation
9914-CH-9030
Not in Commercial Distribution

  • 00817495023557 ()


  • Dermatological solid-state laser system
U OF SASKATCHEWAN LAB FIXED
Peter Brasseler Holdings, LLC
5029857U0
In Commercial Distribution

  • 00887919942122 ()


  • Diamond dental bur, single-use
U OF SASKATCHEWAN CLINIC FIXED
Peter Brasseler Holdings, LLC
5029856U0
In Commercial Distribution

  • 00887919942092 ()


  • Diamond dental bur, single-use
PACIFIC U DIAMCOMP COMP POLISH
Peter Brasseler Holdings, LLC
5022776U0
In Commercial Distribution

  • 00887919676072 ()


  • Diamond dental bur, single-use
PACIFIC U AMALGAM KIT 1P
Peter Brasseler Holdings, LLC
5022774U0
In Commercial Distribution

  • 00887919676058 ()


  • Diamond dental bur, single-use
U OF MARYLAND PROVISIONAL KIT
Peter Brasseler Holdings, LLC
5022508U0
In Commercial Distribution

  • 00887919673378 ()


  • Diamond dental bur, single-use
U OF SASKATCHEWAN FINISHING KIT
Peter Brasseler Holdings, LLC
5017809U0
In Commercial Distribution

  • 00887919627036 ()


  • Diamond dental bur, single-use
U OF SASKATCHEWAN A637BLUE 1P
Peter Brasseler Holdings, LLC
5012312U0
In Commercial Distribution

  • 00887919561255 ()


  • Diamond dental bur, single-use
U OF SASKATCHEWAN A631BLUE 1P
Peter Brasseler Holdings, LLC
5008388U0
In Commercial Distribution

  • 00887919496854 ()


  • Diamond dental bur, single-use
HSB - U/Minnesota Cheek Retractor
Frontier Dental Supply Inc
HSB-300314
In Commercial Distribution

  • 00810132804090 ()


  • Hand-held dental retractor
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