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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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MTP Plate, 5 Holes, Right - 00840118105002

implant for orthopedic bone fixation, compatible with 2.7mm/3.0mm screws
FLOWER ORTHOPEDICS CORPORATION
MFP 011
In Commercial Distribution

  • 00840118105002 ()

  • Height: 1.7 Millimeter


  • Orthopaedic fixation plate, non-bioabsorbable

Elongated L-Plate, 5 Holes, (L), - 00840118104999

Compatible with 2.7mm/3.0mm screws, implants for orthopedic bone fixation
FLOWER ORTHOPEDICS CORPORATION
LFP 112
In Commercial Distribution

  • 00840118104999 ()

  • Height: 1.7 Millimeter


  • Orthopaedic fixation plate, non-bioabsorbable

Locking Fibula Plate, 5 Holes - 00840118110778

Implants for orthopedic bone fixation, compatible with 2.7mm/3.5mm/4.0mm Screws.
FLOWER ORTHOPEDICS CORPORATION
DLF 505
In Commercial Distribution

  • 00840118110778 ()

  • Height: 1.7 Millimeter


  • Orthopaedic fixation plate, non-bioabsorbable

RESPONDER 5, STANDARD,NO ENTERTAINMENT - 00840828164863

RESPONDER 5, STANDARD,NO ENTERTAINMENT
CURBELL MEDICAL PRODUCTS, INC.
4D411U-200000A
In Commercial Distribution

  • 00840828164863 ()
23404

  • Pillow speaker

RESPONDER 5, STANDARD,NO ENTERTAINMENT - 00840828114189

RESPONDER 5, STANDARD,NO ENTERTAINMENT
CURBELL MEDICAL PRODUCTS, INC.
4D411U-201030A
In Commercial Distribution

  • 00840828114189 ()
2681

  • Pillow speaker

RESPONDER 5, STANDARD,NO ENTERTAINMENT - 00840828114172

RESPONDER 5, STANDARD,NO ENTERTAINMENT
CURBELL MEDICAL PRODUCTS, INC.
4D411U-201000A
In Commercial Distribution

  • 00840828114172 ()
2680

  • Pillow speaker

RESPONDER 5, STANDARD,NO ENTERTAINMENT - 00840828114165

RESPONDER 5, STANDARD,NO ENTERTAINMENT
CURBELL MEDICAL PRODUCTS, INC.
4D411U-200060A
In Commercial Distribution

  • 00840828114165 ()
2679

  • Pillow speaker

RESPONDER 5, STANDARD,NO ENTERTAINMENT - 00840828114158

RESPONDER 5, STANDARD,NO ENTERTAINMENT
CURBELL MEDICAL PRODUCTS, INC.
4D411U-001391A
In Commercial Distribution

  • 00840828114158 ()
2678

  • Pillow speaker

RESPONDER 5, STANDARD,NO ENTERTAINMENT - 00840828114141

RESPONDER 5, STANDARD,NO ENTERTAINMENT
CURBELL MEDICAL PRODUCTS, INC.
4D411U-001031A
In Commercial Distribution

  • 00840828114141 ()
2677

  • Pillow speaker

STERNALOCK(TM) SYSTEM 5/PK - 00841036123031

No Description
BIOMET MICROFIXATION, INC
75-6414
In Commercial Distribution

  • 00841036123031 ()
75-6414

  • Sternal fixation device

STERNALOCK(TM) SYSTEM 5/PK - 00841036122867

No Description
BIOMET MICROFIXATION, INC
75-6416
In Commercial Distribution

  • 00841036122867 ()
75-6416

  • Sternal fixation device

Rivacor 5 VR-T DF4 ProMRI - 04035479156916

No Description
BIOTRONIK SE & Co. KG
429565
In Commercial Distribution

  • 04035479156916 ()
429565

  • Single-chamber implantable defibrillator

Rivacor 5 DR-T DF4 ProMRI - 04035479156893

No Description
BIOTRONIK SE & Co. KG
429563
In Commercial Distribution

  • 04035479156893 ()
429563

  • Dual-chamber implantable defibrillator

Iforia 5 VR-T DX DF-1 - 04035479125530

No Description
BIOTRONIK SE & Co. KG
383597
Not in Commercial Distribution

  • 04035479125530 ()
383597

  • Single-chamber implantable defibrillator

STD ProCHO 5 Powder, 50L - 00840075403685

No Description
Lonza Walkersville, Inc.
WPW-045F
In Commercial Distribution

  • 00840075403685 ()
WPW-045F

  • Ex vivo cell culture medium

STD ProCHO 5 Powder, 10L - 00840075403678

No Description
Lonza Walkersville, Inc.
WPW-045D
In Commercial Distribution

  • 00840075403678 ()
WPW-045D

  • Ex vivo cell culture medium

5% Sucrose50mMTris,pH 7.4,2mM MgCl2,100L - 00840075402671

No Description
Lonza Walkersville, Inc.
08-735D
In Commercial Distribution

  • 00840075402671 ()
08-735D

  • Ex vivo cell culture medium

5% Sucrose50mMTris,pH 7.4,2mM MgCl2,10L - 00840075401377

No Description
Lonza Walkersville, Inc.
08-735B
In Commercial Distribution

  • 00840075401377 ()
08-735B

  • Ex vivo cell culture medium

DRUGS OF ABUSE LEVEL 5 - B800DAU5FLE0

DRUGS OF ABUSE LEVEL 5
UTAK LABORATORIES, INC.
DAU 5 F LE
In Commercial Distribution

  • B800DAU5FLE5 ()
  • B800DAU5FLE0 ()

  • Total Volume: 12 Milliliter
DAU 5 F LE

  • Multiple drugs of abuse IVD, control

Spacer 5cm Synthetic 5 piece - 00815165020271

No Description
Eckert & Ziegler Bebig, Inc.
Spacer 5cm Synthetic 5 piece
In Commercial Distribution

  • 00815165020271 ()
SS9X5CMS

  • Manual brachytherapy system
  • Brachytherapy source spacer

TITANIT 5 98H18 with step - D800MEAL98S18

Content: 1 piece Height: 18 mm High-quality medical titanium alloy (Ti-6Al-4V ELI according to ASTM F136 and ISO 5832-3) for the production of metal structures for veneering with ceramic as well as bars and implant constructions. Info: our Titan has a new name: Titanit. Properties and range of applications remain unchanged.
ZIRKONZAHN SRL
MEAL98S18
In Commercial Distribution

  • D800MEAL98S18 ()


  • Dental bridge, metal-ceramic

TITANIT 5 98H16 with step - D800MEAL98S16

Content: 1 piece Height: 16 mm High-quality medical titanium alloy (Ti-6Al-4V ELI according to ASTM F136 and ISO 5832-3) for the production of metal structures for veneering with ceramic as well as bars and implant constructions. Info: our Titan has a new name: Titanit. Properties and range of applications remain unchanged.
ZIRKONZAHN SRL
MEAL98S16
In Commercial Distribution

  • D800MEAL98S16 ()


  • Dental bridge, metal-ceramic

TITANIT 5 98H14 with step - D800MEAL98S14

Content: 1 piece Height: 14 mm High-quality medical titanium alloy (Ti-6Al-4V ELI according to ASTM F136 and ISO 5832-3) for the production of metal structures for veneering with ceramic as well as bars and implant constructions. Info: our Titan has a new name: Titanit. Properties and range of applications remain unchanged.
ZIRKONZAHN SRL
MEAL98S14
In Commercial Distribution

  • D800MEAL98S14 ()


  • Dental bridge, metal-ceramic

Fresco Gingiva 5 (20 g) - D800KEAD63420

Content: 20 g
ZIRKONZAHN SRL
KEAD6342
In Commercial Distribution

  • D800KEAD63420 ()


  • Dental appliance fabrication material, ceramic

Fresco Gingiva 5 (20 g) - D800KEAD6342

Content: 20 g
ZIRKONZAHN SRL
KEAD6342
In Commercial Distribution

  • D800KEAD6342 ()


  • Dental appliance fabrication material, ceramic

Fresco Gingiva 5 (10 g) - D800KEAD63410

Content: 10 g Ceramic pastes for veneering zirconia structures in the gingival region. Colour spectrum: from very light pink (Fresco Gingiva 1) to very dark red (Fresco Gingiva 6).
ZIRKONZAHN SRL
KEAD6341
In Commercial Distribution

  • D800KEAD63410 ()


  • Dental appliance fabrication material, ceramic

Fresco Gingiva 5 (10 g) - D800KEAD6341

Content: 10 g Ceramic pastes for veneering zirconia structures in the gingival region. Colour spectrum: from very light pink (Fresco Gingiva 1) to very dark red (Fresco Gingiva 6).
ZIRKONZAHN SRL
KEAD6341
In Commercial Distribution

  • D800KEAD6341 ()


  • Dental appliance fabrication material, ceramic

COTININE PLUS 5 NG/ML - B800COT5SWDL0

COTININE PLUS 5 NG/ML
UTAK LABORATORIES, INC.
COT+ 5 S WDL
In Commercial Distribution

  • B800COT5SWDL5 ()
  • B800COT5SWDL0 ()

  • Total Volume: 15 Milliliter
COT+ 5 S WDL

  • Multiple-type clinical chemistry analyte profile IVD, control

BUSULFAN CALIBRATOR LEVEL 5 V2 - B800BUSCAL5V2DPFMDACC0

BUSULFAN CALIBRATOR LEVEL 5 V2
UTAK LABORATORIES, INC.
BUS CAL 5 V2 DP F MDACC
In Commercial Distribution

  • B800BUSCAL5V2DPFMDACC5 ()
  • B800BUSCAL5V2DPFMDACC0 ()

  • Total Volume: 1.5 Milliliter
BUS CAL 5 V2 DP F MDACC

  • Multiple-type clinical chemistry analyte profile IVD, control

REVEAL TIP - 5 COUNT BAG - D757X81268P1

No Description
BISCO INC.
X-81268P
Not in Commercial Distribution

  • D757X81268P1 ()

  • sixe text
X-81268P

  • Dental material injection cannula, single-use

Ceramic Tissue 5 (100 g) - D800KEAA6242

Content: 100 g
ZIRKONZAHN SRL
KEAA6242
In Commercial Distribution

  • D800KEAA6242 ()


  • Dental appliance fabrication material, ceramic

Ceramic Tissue 5 (20 g) - D800KEAA6241

Content: 20 g Colour scale from very bright (Tissue 1) to very dark (Tissue 6)
ZIRKONZAHN SRL
KEAA6241
In Commercial Distribution

  • D800KEAA6241 ()


  • Dental appliance fabrication material, ceramic

VOLATILES PLUS 5 MG/DL - B800VOL5MFCL0

VOLATILES PLUS 5 MG/DL
UTAK LABORATORIES, INC.
VOL+ 5 MFCL
In Commercial Distribution

  • B800VOL5MFCL5 ()
  • B800VOL5MFCL0 ()

  • Total Volume: 3 Milliliter
VOL+ 5 MFCL

  • Multiple-type clinical chemistry analyte profile IVD, control

ISAVUCONAZOLE PLUS CALIBRATOR 5 V2 - B800ISACAL5V2SFUCSF0

ISAVUCONAZOLE PLUS CALIBRATOR 5 V2
UTAK LABORATORIES, INC.
ISA+ CAL 5 V2 S F UCSF
In Commercial Distribution

  • B800ISACAL5V2SFUCSF5 ()
  • B800ISACAL5V2SFUCSF0 ()

  • Total Volume: 1 Milliliter
ISA+ CAL 5 V2 S F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control

ETG PLUS CALIBRATOR LEVEL 5 - B800ETGCAL5V2UFUCSF0

ETG PLUS CALIBRATOR LEVEL 5
UTAK LABORATORIES, INC.
ETG+ CAL 5 V2 U F UCSF
In Commercial Distribution

  • B800ETGCAL5V2UFUCSF5 ()
  • B800ETGCAL5V2UFUCSF0 ()

  • Total Volume: 1 Milliliter
ETG+ CAL 5 V2 U F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control

SERUM DRUG SCREEN LEVEL 5 - B800DS5SID0

SERUM DRUG SCREEN LEVEL 5
UTAK LABORATORIES, INC.
DS 5 S ID
In Commercial Distribution

  • B800DS5SID5 ()
  • B800DS5SID0 ()

  • Total Volume: 3 Milliliter
DS 5 S ID

  • Benzodiazepine group IVD, control

DRUGS OF ABUSE LEVEL 5 - B800DAUCAL5V3FNHI0

DRUGS OF ABUSE LEVEL 5
UTAK LABORATORIES, INC.
DAU CAL 5 V3 F NHI
In Commercial Distribution

  • B800DAUCAL5V3FNHI5 ()
  • B800DAUCAL5V3FNHI0 ()

  • Total Volume: 1 Milliliter
DAU CAL 5 V3 F NHI

  • Multiple drugs of abuse IVD, control

DRUGS OF ABUSE CALIBRATOR 5 - B800DAUCAL5UFNPIL0

DRUGS OF ABUSE CALIBRATOR 5
UTAK LABORATORIES, INC.
DAU CAL 5 U F NPIL
In Commercial Distribution

  • B800DAUCAL5UFNPIL5 ()
  • B800DAUCAL5UFNPIL0 ()

  • Total Volume: 2 Milliliter
DAU CAL 5 U F NPIL

  • Multiple-type clinical chemistry analyte profile IVD, control

Alliance Non-Cann Rmr Sz 5 - 00889024632837

No Description
Zimmer, Inc.
SSI006725
In Commercial Distribution

  • 00889024632837 ()

  • Sz 5
SSI006725

  • Bone-resection orthopaedic reamer, reusable

FlexiDisc Mini 5/8 Medium - D7794022581

No Description
COSMEDENT, INC.
402258
In Commercial Distribution

  • D7794022581 ()


  • Hydrogen peroxide (H2O2) IVD, kit, electrometry

FlexiDisc Mini 5/8 Superfine - D7794024581

No Description
COSMEDENT, INC.
402458
In Commercial Distribution

  • D7794024581 ()


  • Dental abrasive disk, single-use

FlexiDisc Mini 5/8 Fine - D7794023581

No Description
COSMEDENT, INC.
402358
In Commercial Distribution

  • D7794023581 ()


  • Dental abrasive disk, single-use

FlexiDisc Mini 5/8 Coarse - D7794021581

No Description
COSMEDENT, INC.
402158
In Commercial Distribution

  • D7794021581 ()


  • Dental abrasive disk, single-use

FlexiDisc Regular 5/8 Coarse - D7794011581

No Description
COSMEDENT, INC.
401158
In Commercial Distribution

  • D7794011581 ()


  • Dental abrasive disk, single-use

MedGyn Shaatz w/drain #5 - M803050125

Shaatz Pessary is used to treat uterine prolapse.
MEDGYN PRODUCTS, INC.
Shaatz w/drain #5
In Commercial Distribution

  • M803050125 ()
050125

  • Pelvic-organ-supporting pessary

MedGyn Pessary Silicone Donut # 5 - M803050015

Pessary Silicone donut is used treat uterine prolapse.
MEDGYN PRODUCTS, INC.
Pessary Silicone Donut # 5
In Commercial Distribution

  • M803050015 ()
050015

  • Pelvic-organ-supporting pessary

PLASTIC PIPETTES 0.3mL - 5 pieces - 07640159161608

PLASTIC PIPETTES ENDO 0.3mL - 5 pieces One assortment of 5 color-coded pipette For introducing solutions into the root canal or cavities
Produits dentaires S.A.
11750
In Commercial Distribution

  • 07640159161608 ()


  • Dental irrigation/aspiration syringe

PLASTIC PIPETTES 1mL - 5 pieces - 07640159161578

PLASTIC PIPETTES 1mL - 5 pieces One assortment of 5 color-coded pipette For introducing solutions into the root canal or cavities
Produits dentaires S.A.
11752
In Commercial Distribution

  • 07640159161578 ()


  • Dental irrigation/aspiration syringe

DS TULSA Generic needle (5) - 07640159161530

DS TULSA generic Irrigation Needle Box of 5 cannulas.
Produits dentaires S.A.
21412
In Commercial Distribution

  • 07640159161530 ()
DSIN30G5

  • Dental irrigation/aspiration syringe

2440 5 WAY BALLOON VALVE - 00817136026848

MOD 2440B 5WAY INFLBAL FOR MRI
HANS RUDOLPH, INC.
2440
Not in Commercial Distribution

  • 00817136026848 ()
CR1676

  • Pulmonary function valve
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