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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SENTINEL 11 / PATHFINDER SL KIT FR
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
Not in Commercial Distribution

  • 10841522129315 ()
040-1748-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 11 NETWORKED TEST SYSTEM
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522129292 ()
040-1723-01

  • Cardiology information system application software
SENTINEL 11 STANDALONE TEST SYSTEM
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522129285 ()
040-1722-01

  • Cardiology information system application software
SENTINEL SOFTWARE V11
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinel 11
In Commercial Distribution

  • 10841522125751 ()
98201

  • Cardiology information system application software
NIC TONE Orthodontic Acrylic #11 500 g
MDC DENTAL
Orthodontic #11
In Commercial Distribution

  • 07506338319522 ()


  • Dental acrylic resin
NIC TONE Orthodontic Acrylic #11 190 g
MDC DENTAL
Orthodontic #11
In Commercial Distribution

  • 07506338319515 ()


  • Dental acrylic resin
NIC TONE Orthodontic Acrylic #11 90 g
MDC DENTAL
Orthodontic #11
In Commercial Distribution

  • 07506338319508 ()


  • Dental acrylic resin
NIC TONE Orthodontic Acrylic #11 35 g
MDC DENTAL
Orthodontic #11
In Commercial Distribution

  • 07506338319492 ()


  • Dental acrylic resin
NIC TONE QUARZ Rapid Acrylic #11 35 g
MDC DENTAL
Rapid #11
In Commercial Distribution

  • 07506338319027 ()


  • Dental acrylic resin
WinSlate 11 Speech Generating Device
FORBES REHAB SERVICES INC
WinSlate 11
In Commercial Distribution

  • B398WS110 ()


  • Voice synthesizer/digitizer
EXP C U4-4 LME U5-L5-5 022 hks 345
Gc Orthodontics America Inc.
11/32-2CC5-6338
In Commercial Distribution

  • D78811322CC563381 ()
11/32-2CC5-6338

  • Orthodontic bracket, ceramic
  • Orthodontic bracket, metal
EXC BIDI MBT U5-5/L3-3 EXP M L45 HK 345
Gc Orthodontics America Inc.
11/20-BID5-X589
In Commercial Distribution

  • D7881120BID5X5891 ()
11/20-BID5-X589

  • Orthodontic bracket, metal
  • Orthodontic bracket, ceramic
EXC U 5-5/EXM L 5-5 022 HK 345
Gc Orthodontics America Inc.
11/20-2CC5-X224
In Commercial Distribution

  • D78811202CC5X2241 ()
11/20-2CC5-X224

  • Orthodontic bracket, ceramic
  • Orthodontic bracket, metal
EXP C ACO U5-5, EXPMBT L5-5 022 HKS3,4,5
Gc Orthodontics America Inc.
11/20-2CC5-9752
In Commercial Distribution

  • D78811202CC597521 ()
11/20-2CC5-9752

  • Orthodontic bracket, metal
  • Orthodontic bracket, ceramic
EXC MBT 022 U 5-5/ EXM L 5-5 HK 345
Gc Orthodontics America Inc.
11/20-2CC5-0020
In Commercial Distribution

  • D78811202CC500201 ()
11/20-2CC5-0020

  • Orthodontic bracket, ceramic
  • Orthodontic bracket, metal
EXP CU4-4 L3-3, MU5 L45 022 HKS 3,4
Gc Orthodontics America Inc.
11/20-2CC4-5435
In Commercial Distribution

  • D78811202CC454350 ()
  • D78811202CC454351 ()
11/20-2CC4-5435

  • Orthodontic bracket, ceramic
EXP CER U 5-5 L3-3 EXM L 45 HK 3
Gc Orthodontics America Inc.
11/20-2CC3-0030
In Commercial Distribution

  • D78811202CC300301 ()
11/20-2CC3-0030

  • Orthodontic bracket, ceramic
EXC U5-5 L3-3, EXM L4/5 CCO 022 HKS 345
Gc Orthodontics America Inc.
11/20-2CC5-0007
In Commercial Distribution

  • D78811202CC00071 ()
11/20-2CC5-0007

  • Orthodontic bracket, ceramic
EXP M ROTH 022 UL6-6 HK 3,4,5
Gc Orthodontics America Inc.
11/20-2BB5-7747
In Commercial Distribution

  • D78811202BB577471 ()
11/20-2BB5-7747

  • Orthodontic bracket, metal
EXC/EXM 022 MBT U 6-6 HK 34
Gc Orthodontics America Inc.
11/20-2B04-8439
In Commercial Distribution

  • D78811202B0484391 ()
11/20-2B04-8439

  • Orthodontic bracket, ceramic
  • Orthodontic bracket, metal
EXC ACO 022 U 6-6/ EXM L 7-7 HK 345
Gc Orthodontics America Inc.
11/20-2AA5-9780
In Commercial Distribution

  • D78811202AA597801 ()
11/20-2AA5-9780

  • Orthodontic bracket, metal
  • Orthodontic bracket, ceramic
EXPC CCO U5-5 EXPM MBT L5-5 022 hks345
Gc Orthodontics America Inc.
11/20-2AA5-9752
In Commercial Distribution

  • D78811202AA597521 ()
11/20-2AA5-9752

  • Orthodontic bracket, ceramic
EXPC/M ROTH 022 UL 7-7 HK 3,4,5
Gc Orthodontics America Inc.
11/20-2AA5-9380
In Commercial Distribution

  • D78811202AA593801 ()
11/20-2AA5-9380

  • Orthodontic bracket, ceramic
  • Orthodontic bracket, metal
EXC U 3-3/ EXP M U45, L 5-5 HK 345
Gc Orthodontics America Inc.
11/20-2AA5-8366
In Commercial Distribution

  • D78811202AA583661 ()
11/20-2AA5-8366

  • Orthodontic bracket, metal
  • Orthodontic bracket, ceramic
EXPC/M MBT 022 U/L 7-7 HK 3,4,5
Gc Orthodontics America Inc.
11/20-2AA5-7958
In Commercial Distribution

  • D78811202AA579581 ()
11/20-2AA5-7958

  • Orthodontic bracket, ceramic
EXC U3-3, EXM 4-7, 7-7 CCO 022 HKS 3,4,5
Gc Orthodontics America Inc.
11/20-2AA5-2561
In Commercial Distribution

  • D78811202AA525611 ()
11/20-2AA5-2561

  • Orthodontic bracket, ceramic
EXP C ACO, L 4/5M 022 UL 7-7 FEM 3,4,5HK
Gc Orthodontics America Inc.
11/20-2AA5-0168
In Commercial Distribution

  • D78811202AA501681 ()
11/20-2AA5-0168

  • Orthodontic bracket, ceramic
  • Orthodontic bracket, metal
EXP C U/L 5-5 L 3-3 EXP M L 4,5 HK 345
Gc Orthodontics America Inc.
11/20-1CC5-1120
In Commercial Distribution

  • D78811201CC511201 ()
11/20-1CC5-1120

  • Orthodontic bracket, ceramic
EXC 4-4 EXM RH MBT 022/UL 5-5,3,4,5HK
Gc Orthodontics America Inc.
11/19-2CC5-2424
In Commercial Distribution

  • D78811192CC524240 ()
  • D78811192CC524241 ()
11/19-2CC5-2424

  • Orthodontic bracket, ceramic
EXPC RH MBT 022 UL 5-5 U34 L345 HK
Gc Orthodontics America Inc.
11/19-2C45-0020
In Commercial Distribution

  • D78811192C4500200 ()
  • D78811192C4500201 ()
11/19-2C45-0020

  • Orthodontic bracket, ceramic
EXPC U4-4 L3-3/EXMRC U5 L45 ROTH 018 HK
Gc Orthodontics America Inc.
11/19-1CC5-7921
In Commercial Distribution

  • D78811191CC579211 ()
11/19-1CC5-7921

  • Orthodontic bracket, metal
  • Orthodontic bracket, ceramic
EXP C/EXMRC ROTH 018 U/L 5-5 HK 345
Gc Orthodontics America Inc.
11/19-1CC5-1120
In Commercial Distribution

  • D78811191CC511201 ()
11/19-1CC5-1120

  • Orthodontic bracket, metal
  • Orthodontic bracket, ceramic
Taper Uncemented Femoral Stem Size 11/128° Mini TR
MAXX ORTHOPEDICS, INC.
MO-STRC-28/11
In Commercial Distribution

  • 00810008126608 ()


  • Press-fit femoral stem prosthesis
SENTINEL V11.X UPGRADE
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522129506 ()
040-5172-00

  • Cardiology information system application software
BIPOLAR FORCEPS ADSON
Bausch & Lomb Incorporated
S2050 11
In Commercial Distribution

  • 00757770404582 ()
S2050 11

  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
No Description
Bain Medical Equipment (Guangzhou) Co., Ltd.
BL 11
In Commercial Distribution

  • 16948082702102 ()
  • 06948082702105 ()


  • Haemodialysis blood tubing set, single-use
Broach, Tibial Cone XS Full
Link Bio Corp
87-1903/11
In Commercial Distribution

  • 00810022402795 ()


  • Orthopaedic broach
Reamer, Tibial Cone, XS/S Full
Link Bio Corp
87-1909/11
In Commercial Distribution

  • 00810022402412 ()


  • Bone-resection orthopaedic reamer, reusable
Broach, Tibial Cone, XS Full
Link Bio Corp
87-1901/11
In Commercial Distribution

  • 00810022402115 ()
87-1901/11

  • Orthopaedic broach
Taper Uncemented Femoral Stem Size 11/132° Lateral Distal Reduction
MAXX ORTHOPEDICS, INC.
MO-STOC-32/11
In Commercial Distribution

  • 00810008124093 ()


  • Metal-on-polyethylene total hip prosthesis
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