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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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Cytal® - 00386190001011

Burn Matrix 5 X 5 cm
ACELL, INC.
BMM0505
Not in Commercial Distribution

  • 00386190001011 ()

  • Rectangle device approximately 5 x 5 cm
BMM0505

  • Animal-derived wound matrix dressing

MatriStem - 00386190000403

Surgical Matrix 5 x 5 cm
ACELL, INC.
PSMX0505
Not in Commercial Distribution

  • 00386190000403 ()

  • Rectangle device approximately 5 x 5 cm
PSMX0505

  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial

ParaPost Fiber Lux - D661PF17151

5 ParaPost FiberLux Posts, Size 5
COLTENE/WHALEDENT INC
PF1715
In Commercial Distribution

  • D661PF17151 ()
  • D661PF17150 ()
  • 00840016201707 ()


  • Root canal post, preformed

gSource - 00840314210135

Bunge Evisceration Spoon 5", #5, 12.0mm
GSOURCE LLC
gS 27.7712
In Commercial Distribution

  • 00840314210135 ()
gS 27.7712

  • Lens spoon

Halyard - 10680651136876

SURGPN,400X5+5,PMPSAF,-,OQ,5
Avanos Medical, Inc.
13687
In Commercial Distribution

  • 30680651136870 ()
  • 10680651136876 ()
P400X5 plus5-60

  • Elastomeric infusion pump system

Halyard - 10680651136869

SURGPN,400X2-14+5,PMPSAF,-,OQ,5
Avanos Medical, Inc.
13686
In Commercial Distribution

  • 30680651136863 ()
  • 10680651136869 ()
P400X2-14 plus5

  • Elastomeric infusion pump system

Halyard - 10680651136845

SURGPN,400X1-7+5,PMPSAF,-,OQ,5
Avanos Medical, Inc.
13684
In Commercial Distribution

  • 30680651136849 ()
  • 10680651136845 ()
P400X1-7 plus5-

  • Elastomeric infusion pump system

Halyard - 10680651134803

SURGPN,400X5+5,CBI,-,OQ,5
Avanos Medical, Inc.
13480
In Commercial Distribution

  • 30680651134807 ()
  • 10680651134803 ()
CBI003

  • Elastomeric infusion pump system

Phospholin ES w/Calcium - 10859394006238

APTT reagent 5 x 5 ml
R 2 DIAGNOSTICS, INC.
21-405
In Commercial Distribution

  • 10859394006238 ()
  • 00859394006231 ()
21-405

  • Activated partial thromboplastin time (APTT) IVD, reagent

Supremo Instrumentos - 07908854000340

Tunelizador 5 (DLC) - Tunneler 5 DLC
ANDRE GREGATE BRAGA INSTRUMENTOS LTDA
S2937B
In Commercial Distribution

  • 07908854000340 ()
S2937B

  • Periosteal elevator, reusable

APTUS - 07630037848912

5/5 Case Effective Height 96mm
Medartis AG
A-6517
In Commercial Distribution

  • 07630037848912 ()
A-6517

  • Device sterilization/disinfection container, reusable

APTUS - 07630037848868

5/5 Case Effective Height 48mm
Medartis AG
A-6507
In Commercial Distribution

  • 07630037848868 ()
A-6507

  • Device sterilization/disinfection container, reusable

APTUS - 07630037848844

5/5 Case Effective Height 144mm
Medartis AG
A-6505
In Commercial Distribution

  • 07630037848844 ()
A-6505

  • Device sterilization/disinfection container, reusable

BOSS Instruments - 00888515154834

Hoke Osteotome, cvd, 5", 5/8"
BOSS INSTRUMENTS, LTD., INC.
70-3756
In Commercial Distribution

  • 00888515154834 ()
70-3756

  • Orthopaedic osteotome

BOSS Instruments - 00888515154773

Hoke Osteotome, cvd, 5", 5/16"
BOSS INSTRUMENTS, LTD., INC.
70-3753
In Commercial Distribution

  • 00888515154773 ()
70-3753

  • Orthopaedic osteotome

BOSS Instruments - 00888515154698

Hoke Osteotome, str, 5", 5/8"
BOSS INSTRUMENTS, LTD., INC.
70-3736
In Commercial Distribution

  • 00888515154698 ()
70-3736

  • Orthopaedic osteotome

BOSS Instruments - 00888515154636

Hoke Osteotome, str, 5", 5/16"
BOSS INSTRUMENTS, LTD., INC.
70-3733
In Commercial Distribution

  • 00888515154636 ()
70-3733

  • Orthopaedic osteotome

APTUS - 07630894803543

5/5 Case Effective Height 96mm
Medartis AG
A-6517
In Commercial Distribution

A-6517

  • Device sterilization/disinfection container, reusable

APTUS - 07630894803444

5/5 Case Effective Height 48mm
Medartis AG
A-6507
In Commercial Distribution

A-6507

  • Device sterilization/disinfection container, reusable

APTUS - 07630894803413

5/5 Case Effective Height 144mm
Medartis AG
A-6505
In Commercial Distribution

A-6505

  • Device sterilization/disinfection container, reusable

Surgical Direct - B382SD923867160

5 5/8 inch Spatula Packer
Surgical Direct, Inc.
SD92386716
In Commercial Distribution

  • B382SD923867160 ()
SD92386716

  • Bone lever/elevator, reusable

Surgical Direct - B382SD920686200

5 5/8" Drum Elevator, 2.0mm
Surgical Direct, Inc.
SD92068620
In Commercial Distribution

  • B382SD920686200 ()
SD92068620

  • Periosteal elevator, reusable

ELEVATOR - 00888118059598

SEPTUM, COTTLE, 5/5 MM TIP
KLS-Martin L.P.
37-559-23-07
In Commercial Distribution

  • 00888118059598 ()

  • 23 CM


  • ENT elevator

NA - 00810050245425

WEDGE, 5" x 5" x 15"
DOMICO MED-DEVICE, LLC
108-8
Not in Commercial Distribution

  • 00810050245425 ()

  • Height: 5 Inch
  • Width: 5 Inch
  • Length: 15 Inch


  • Multifunction body cushion
  • Radiological general body-part positioner

NA - 00810050244794

WEDGE, 5" x 5" x 15"
DOMICO MED-DEVICE, LLC
108
In Commercial Distribution

  • 00810050244794 ()

  • Height: 5 Inch
  • Width: 5 Inch
  • Length: 15 Inch


  • Multifunction body cushion
  • Radiological general body-part positioner

Synchron - 15099590221256

CAL 5 PLUS Calibrator 5 Plus
Beckman Coulter, Inc.
469975
In Commercial Distribution

  • 15099590221256 ()
469975

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Pryor - 00761887000957

5 leg knockdown,5 hook, SW
PRYOR PRODUCTS
136T
In Commercial Distribution

  • 00761887000957 ()
136T

  • Freestanding/bed-attached intravenous pole

Buprenorphine 5 Qualitative Calibrator Set - 00850624008070

BUP 5 Cutoff Calibrator 5 ng/mL (1 x 5 mL).
LIN-ZHI INTERNATIONAL, INC.
08356661190
In Commercial Distribution

  • 00850624008070 ()
08356661190

  • Buprenorphine IVD, calibrator

GEN2 - 00840343726515

BOWMAN LACRIMAL PROBE, STERLING SILVER, SIZE #5/6, 5 5/8"
SURGIX MEDICAL LLC
G2G35828
In Commercial Distribution

  • 00840343726515 ()

  • Length: 5.625 Inch
G2G35828

  • Ophthalmic surgical probe, reusable

Snowden-Pencer - 70885403465644

Snowden-Pencer MIS TROCAR VALVE PACK OF 5 5/PK X 5
STERIS CORPORATION
TV5-5
In Commercial Distribution

  • 70885403465644 ()
  • 10885403465642 ()
TV55

  • Laparoscopic trocar blade, reusable

Anaesthetic Mask, Size 5# - 06923310903530

No Description
Hangzhou Formed Medical Devices Co.Ltd.
PA150205
In Commercial Distribution

  • 06923310903530 ()
PA150205

  • Anaesthesia face mask, single-use

VISION 5/13 L-WRENCH - 00880304491946

No Description
Biomet Orthopedics, LLC
14270
In Commercial Distribution

  • 00880304491946 ()
14270

  • Surgical torque wrench, reusable

Dorsal Columella Style 5 - M724400544S1

Nasal Implant
IMPLANTECH ASSOCIATES, INC.
Size 4
In Commercial Distribution

  • M724400544S1 ()
400-544S

  • Nasal cartilage support implant, non-bioabsorbable

Dorsal Columella Style 5 - M724400534S1

Nasal Implant
IMPLANTECH ASSOCIATES, INC.
Size 3
In Commercial Distribution

  • M724400534S1 ()
400-534S

  • Nasal cartilage support implant, non-bioabsorbable

Dorsal Columella Style 5 - M724400524S1

Nasal Implant
IMPLANTECH ASSOCIATES, INC.
Size 2
In Commercial Distribution

  • M724400524S1 ()
400-524S

  • Nasal cartilage support implant, non-bioabsorbable

Dorsal Columella Style 5 - M724400514S1

Nasal Implant
IMPLANTECH ASSOCIATES, INC.
Size 1
In Commercial Distribution

  • M724400514S1 ()
400-514S

  • Nasal cartilage support implant, non-bioabsorbable

MOSAIC INSTRUMENT CASE #5 - 00880304397149

No Description
Biomet Orthopedics, LLC
595151
In Commercial Distribution

  • 00880304397149 ()
595151

  • Instrument tray, reusable

DISCOVERY ELBOW 5 STEP - 00880304370333

No Description
Biomet Orthopedics, LLC
414912
In Commercial Distribution

  • 00880304370333 ()
414912

  • Bone-resection orthopaedic reamer, reusable

React Health Phoenix 5 - 06934726614439

No Description
Longfian Scitech Co., Ltd.
SOC5100
In Commercial Distribution

  • 06934726614439 ()


  • Mobile/portable oxygen concentrator

EPIQ 5 Ultrasound System - 00884838107502

No Description
Philips Ultrasound LLC
795204
In Commercial Distribution

  • 00884838107502 ()


  • General-purpose ultrasound imaging system

FJ Clip Neo 5 - 00883475954753

No Description
CHARMANT INC.
24-0003
In Commercial Distribution

  • 00883475954753 ()


  • Gastrointestinal endoscopic clip applier

ALI-HAND XLG 5/PK - 00733657239393

No Description
ALIMED, INC.
931036
In Commercial Distribution

  • 00733657239393 ()
  • 00733657299441 ()
2970013247

  • Hand/finger splint, reusable

ALI-HAND STD 5/PK - 00733657239386

No Description
ALIMED, INC.
931035
In Commercial Distribution

  • 00733657239386 ()
  • 00733657299434 ()
2970013246

  • Hand/finger splint, reusable

PAR 5 HIP SYSTEM - 00880304197404

No Description
Biomet Orthopedics, LLC
109272
In Commercial Distribution

  • 00880304197404 ()

  • 72 MM 26 LINER SIZE
109272

  • Acetabular shell

PAR 5 HIP SYSTEM - 00880304197381

No Description
Biomet Orthopedics, LLC
109268
In Commercial Distribution

  • 00880304197381 ()

  • 68 MM 25 LINER SIZE
109268

  • Acetabular shell

PAR 5 HIP SYSTEM - 00880304197374

No Description
Biomet Orthopedics, LLC
109264
In Commercial Distribution

  • 00880304197374 ()

  • 64 MM 24 LINER SIZE
109264

  • Acetabular shell

PAR 5 HIP SYSTEM - 00880304197350

No Description
Biomet Orthopedics, LLC
109260
In Commercial Distribution

  • 00880304197350 ()

  • 60 MM 23 LINER SIZE
109260

  • Acetabular shell

PAR 5 HIP SYSTEM - 00880304197343

No Description
Biomet Orthopedics, LLC
109256
In Commercial Distribution

  • 00880304197343 ()

  • 56 MM 23 LINER SIZE
109256

  • Acetabular shell

PAR 5 HIP SYSTEM - 00880304197282

No Description
Biomet Orthopedics, LLC
109220
In Commercial Distribution

  • 00880304197282 ()
109220

  • Coated hip femur prosthesis, modular

Tenzing 5 delivery catheter - 00853799007619

Tenzing 5 delivery catheter
ROUTE 92 MEDICAL
Gen 1
In Commercial Distribution

  • 00853799007619 ()


  • Thrombectomy suction catheter
  • Vascular guide-catheter, single-use
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