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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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Dialysate Sack (SAK) with Concentrate - M535SAK307A0

No Description
NXSTAGE MEDICAL, INC.
SAK-307-A
In Commercial Distribution

  • M535SAK307A5 ()
  • M535SAK307A0 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK3070

No Description
NXSTAGE MEDICAL, INC.
SAK-307
In Commercial Distribution

  • M535SAK3075 ()
  • M535SAK3070 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK306A0

No Description
NXSTAGE MEDICAL, INC.
SAK-306-A
In Commercial Distribution

  • M535SAK306A5 ()
  • M535SAK306A0 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK3060

No Description
NXSTAGE MEDICAL, INC.
SAK-306
In Commercial Distribution

  • M535SAK3065 ()
  • M535SAK3060 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK305A0

No Description
NXSTAGE MEDICAL, INC.
SAK-305-A
In Commercial Distribution

  • M535SAK305A5 ()
  • M535SAK305A0 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK3050

No Description
NXSTAGE MEDICAL, INC.
SAK-305
In Commercial Distribution

  • M535SAK3055 ()
  • M535SAK3050 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK304A0

No Description
NXSTAGE MEDICAL, INC.
SAK-304-A
In Commercial Distribution

  • M535SAK304A5 ()
  • M535SAK304A0 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK3040

No Description
NXSTAGE MEDICAL, INC.
SAK-304
In Commercial Distribution

  • M535SAK3045 ()
  • M535SAK3040 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK303A0

No Description
NXSTAGE MEDICAL, INC.
SAK-303-A
In Commercial Distribution

  • M535SAK303A5 ()
  • M535SAK303A0 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK3030

No Description
NXSTAGE MEDICAL, INC.
SAK-303
In Commercial Distribution

  • M535SAK3035 ()
  • M535SAK3030 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK302A0

No Description
NXSTAGE MEDICAL, INC.
SAK-302-A
In Commercial Distribution

  • M535SAK302A5 ()
  • M535SAK302A0 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK3020

No Description
NXSTAGE MEDICAL, INC.
SAK-302
In Commercial Distribution

  • M535SAK3025 ()
  • M535SAK3020 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK301A0

No Description
NXSTAGE MEDICAL, INC.
SAK-301-A
In Commercial Distribution

  • M535SAK301A5 ()
  • M535SAK301A0 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK3010

No Description
NXSTAGE MEDICAL, INC.
SAK-301
In Commercial Distribution

  • M535SAK3015 ()
  • M535SAK3010 ()


  • Haemodialysis concentrate

H-Pette with Blade (1000 pieces) - M52536120

No Description
HELENA LABORATORIES CORPORATION
3612
In Commercial Distribution

  • M52536120 ()


  • Blood/blood culture specimen transfer spike IVD, manual

Dialysate Sack (SAK) with Concentrate - M535SAK407A0

No Description
NXSTAGE MEDICAL, INC.
SAK-407-A
In Commercial Distribution

  • M535SAK407A5 ()
  • M535SAK407A0 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK4070

No Description
NXSTAGE MEDICAL, INC.
SAK-407
In Commercial Distribution

  • M535SAK4075 ()
  • M535SAK4070 ()


  • Haemodialysis concentrate

NXSTAGE CARTRIDGE EXPRESS WITH SPEEDSWAP - M535CAR5350

No Description
NXSTAGE MEDICAL, INC.
CAR-535
In Commercial Distribution

  • M535CAR5355 ()
  • M535CAR5350 ()


  • Haemodialysis/haemofiltration system component set

Handle with AO connection system - 08437019739324

Accessory handle used to insert instruments with AO connection.
ABANZA TECNOMED SL.
21
In Commercial Distribution

  • 08437019739324 ()
  • 28437019739328 ()


  • Surgical instrument handle, non-torque-limiting

BRT Verification Samples with CRP - EABA10090211

BRT Verification Samples are human liquid serum samples used to verify analyte linearity over the reportable range.
Bioresource Technology
100-9021
In Commercial Distribution

  • EABA10090210 ()
  • EABA10090211 ()
100-9021

  • Multiple-type clinical chemistry analyte profile IVD, control

PRETTAU 3 98H25 with step - D800ZROA0971

Content: 1 piece Height: 25 mm
ZIRKONZAHN SRL
ZROA0971
In Commercial Distribution

  • D800ZROA0971 ()


  • Dental appliance fabrication material, ceramic

PRETTAU 3 98H16 with step - D800ZROA0962

Content: 1 piece Height: 16 mm
ZIRKONZAHN SRL
ZROA0962
In Commercial Distribution

  • D800ZROA0962 ()


  • Dental appliance fabrication material, ceramic

PRETTAU 3 98H22 with step - D800ZROA0951

Content: 1 piece Height: 22 mm
ZIRKONZAHN SRL
ZROA0951
In Commercial Distribution

  • D800ZROA0951 ()


  • Dental appliance fabrication material, ceramic

PRETTAU 3 98H12 with step - D800ZROA0941

Content: 1 piece Height: 12 mm
ZIRKONZAHN SRL
ZROA0941
In Commercial Distribution

  • D800ZROA0941 ()


  • Dental appliance fabrication material, ceramic

PRETTAU 3 98H20 with step - D800ZROA0931

Content: 1 piece Height: 20 mm
ZIRKONZAHN SRL
ZROA0931
In Commercial Distribution

  • D800ZROA0931 ()


  • Dental appliance fabrication material, ceramic

PRETTAU 3 98H18 with step - D800ZROA0921

Content: 1 piece Height: 18 mm
ZIRKONZAHN SRL
ZROA0921
In Commercial Distribution

  • D800ZROA0921 ()


  • Dental appliance fabrication material, ceramic

PRETTAU 3 98H14 with step - D800ZROA0911

Content: 1 piece Height: 14 mm
ZIRKONZAHN SRL
ZROA0911
In Commercial Distribution

  • D800ZROA0911 ()


  • Dental appliance fabrication material, ceramic

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVK2030NC0

Tru-Incise Valvulotome
URESIL, LLC
TIVK2030
Not in Commercial Distribution

  • H862TIVK2030NC2 ()
  • H862TIVK2030NC1 ()
  • H862TIVK2030NC0 ()

  • Length: 94 Centimeter
TIVK2030

  • Valvulotome, percutaneous

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVK20300

Tru-Incise Valvulotome
URESIL, LLC
TIVK2030
Not in Commercial Distribution

  • H862TIVK20302 ()
  • H862TIVK20301 ()
  • H862TIVK20300 ()

  • Length: 94 Centimeter
TIVK2030

  • Vein stripper, single-use

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVH40NC0

Tru-Incise 4mm Cutting Head
URESIL, LLC
TIVH40
Not in Commercial Distribution

  • H862TIVH40NC2 ()
  • H862TIVH40NC1 ()
  • H862TIVH40NC0 ()

  • Outer Diameter: 4 Millimeter
TIVH40

  • Valvulotome, percutaneous

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVH400

Tru-Incise 4mm Cutting Head
URESIL, LLC
TIVH40
Not in Commercial Distribution

  • H862TIVH402 ()
  • H862TIVH401 ()
  • H862TIVH400 ()

  • Outer Diameter: 4 Millimeter
TIVH40

  • Vein stripper, single-use

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVH30NC0

Tru-Incise 3mm Cutting Head
URESIL, LLC
TIVH30
Not in Commercial Distribution

  • H862TIVH30NC2 ()
  • H862TIVH30NC1 ()
  • H862TIVH30NC0 ()

  • Outer Diameter: 3 Millimeter
TIVH30

  • Valvulotome, percutaneous

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVH300

Tru-Incise 3mm Cutting Head
URESIL, LLC
TIVH30
Not in Commercial Distribution

  • H862TIVH302 ()
  • H862TIVH301 ()
  • H862TIVH300 ()

  • Outer Diameter: 3 Millimeter
TIVH30

  • Vein stripper, single-use

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVH20NC0

Tru-Incise 2mm Cutting Head
URESIL, LLC
TIVH20
Not in Commercial Distribution

  • H862TIVH20NC2 ()
  • H862TIVH20NC1 ()
  • H862TIVH20NC0 ()

  • Outer Diameter: 2 Micrometer
TIVH20

  • Valvulotome, percutaneous

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVCNC0

Tru-Incise Valvulotome Catheter Kit
URESIL, LLC
TIVC
Not in Commercial Distribution

  • H862TIVCNC2 ()
  • H862TIVCNC1 ()
  • H862TIVCNC0 ()

  • Length: 94 Centimeter
TIVC

  • Valvulotome, percutaneous

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVC0

Tru-Incise Valvulotome Catheter Kit
URESIL, LLC
TIVC
Not in Commercial Distribution

  • H862TIVC2 ()
  • H862TIVC1 ()
  • H862TIVC0 ()

  • Length: 94 Centimeter
TIVC

  • Vein stripper, single-use

Grooved Director With Tongue Tie - 00192896107908

Grooved Director With Tongue Tie Stainless Steel
SONTEC INSTRUMENTS, INC.
197-691
In Commercial Distribution

  • 00192896107908 ()

  • Length: 5 Inch
197-691

  • Gastro-urological director

ON-Q* C-Bloc with Dual SELECT-A-FLOW* - 00193494134778

ON-Q* C-Bloc with Dual SELECT-A-FLOW* 600 ml x 1-7 ml/hr + 1-7 ml/hr
Avanos Medical, Inc.
13477
In Commercial Distribution

  • 10193494134775 ()
  • 00193494134778 ()

  • Total Volume: 600 Milliliter
  • Balloon Fill Volume (ml)
CB6007

  • Elastomeric infusion pump system

HONAN BALLOON WITH PRESS VALVE - 00841668112137

No Description
KATENA PRODUCTS, INC.
K 9-8410
In Commercial Distribution

  • 00841668112137 ()
K 9-8410

  • Intraocular pressure-reducing compression system

TDX SP2 with LiNX Electronics - 00841447100911

No Description
INVACARE CORPORATION
TDXSP2
Not in Commercial Distribution

  • 00841447100911 ()


  • Electric-motor-driven wheelchair, occupant-controlled

ic adapter with hexagon ball - 04048844124427

No Description
implantcast GmbH
75123608
In Commercial Distribution

  • 04048844124427 ()

  • 8mm


  • Orthopaedic implant-instrument extension adaptor, reusable

Vent Set COAX with Holder - 04048675026648

No Description
Drägerwerk AG & Co. KGaA
MP00316
Not in Commercial Distribution

  • 04048675026648 ()
  • 04048675422303 ()


  • Ventilator breathing circuit, single-use

BAYONETTE TURBINATE ELECTRODE WITH HP - 00841494102036

BAYONETTE TURBINATE ELECTRODE WITH HP
Cynosure, LLC
IEC-I6D
In Commercial Distribution

  • 00841494102036 ()
IEC-I6D

  • Open-surgery electrosurgical electrode, monopolar, reusable

parawalk 5m with wooden plate - 04050588002053

No Description
h/p/cosmos sports & medical gmbh
cos30020va01
In Commercial Distribution

  • 04050588002053 ()
cos30020va01

  • Parallel bar exerciser, non-powered

parawalk 4m with wooden plate - 04050588002039

No Description
h/p/cosmos sports & medical gmbh
cos30019va01
In Commercial Distribution

  • 04050588002039 ()
cos30019va01

  • Parallel bar exerciser, non-powered

parawalk 3m with wooden plate - 04050588002015

No Description
h/p/cosmos sports & medical gmbh
cos30018va01
In Commercial Distribution

  • 04050588002015 ()
cos30018va01

  • Parallel bar exerciser, non-powered

THORPE FORCEPS WITH LASER LINES - 00841668133293

THORPE FORCEPS WITH LASER LINES
KATENA PRODUCTS, INC.
AE-4159N
In Commercial Distribution

  • 00841668133293 ()
AE-4159N

  • Dressing/utility forceps, tweezers-like, reusable

Alignment Software Cranial with LITT - 04056481146337

No Description
Brainlab AG
2.1
In Commercial Distribution

  • 04056481146337 ()


  • Electromagnetic/optical surgical navigation device tracking system

THROPE FORCEPS WITH LASER LINES - 00841668133286

THROPE FORCEPS WITH LASER LINES
KATENA PRODUCTS, INC.
AE-4159
In Commercial Distribution

  • 00841668133286 ()
AE-4159

  • Dressing/utility forceps, tweezers-like, reusable

Mattress with flat surface PHS1 - 04056869008806

No Description
Siemens Shanghai Medical Equipment Ltd.
10414762
In Commercial Distribution

  • 04056869008806 ()


  • Full-body CT system
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