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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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Hermetic™ II - 10381780542193

Hermetic™ II External CSF Drainage Management
Integra Lifesciences Corporation
NL8508300N
In Commercial Distribution


  • 700ml drainage bag, 50ml burette, 200cm striped tubing line
NL8508300N

  • Lumbar cerebrospinal fluid drainage catheterization kit
  • Ventricular cerebrospinal fluid drainage catheterization kit

DJO SURGICAL - 00888912127745

SAW CAPTURE, .050 BLADE, TYPE 2, EXTERNAL
Encore Medical, L.P.
801-01-170
In Commercial Distribution

  • 00888912127745 ()


  • Manual surgical saw blade, flexible, reusable

DJO SURGICAL - 00888912127431

SAW CAPTURE, .040 BLADE, TYPE 2, EXTERNAL
DJO, LLC
801-01-139
In Commercial Distribution

  • 00888912127431 ()


  • Osteotomy guide, reusable

Soft-Form™ ALD External Nasal Splint - 00818501022649

Soft-Form™ ALD External Nasal Splint, Plain
INVOTEC INTERNATIONAL, INC.
20-10310B
In Commercial Distribution

  • 10818501022646 ()
  • 00818501022649 ()
20-10310B

  • External nasal splint

Soft-Form™ ALD External Nasal Splint - 00818501022632

Soft-Form™ ALD External Nasal Splint, Small
INVOTEC INTERNATIONAL, INC.
20-10301
In Commercial Distribution

  • 10818501022639 ()
  • 00818501022632 ()
20-10301

  • External nasal splint

Soft-Form™ AL External Nasal Splint - 00818501022588

Soft-Form™ AL External Nasal Splint, Small
INVOTEC INTERNATIONAL, INC.
20-10201
In Commercial Distribution

  • 10818501022585 ()
  • 00818501022588 ()
20-10201

  • External nasal splint

Soft-Form™ AL External Nasal Splint - 00818501022571

Soft-Form™ AL External Nasal Splint, Regular
INVOTEC INTERNATIONAL, INC.
20-10211
In Commercial Distribution

  • 10818501022578 ()
  • 00818501022571 ()
20-10211

  • External nasal splint

Soft-Form™ AL External Nasal Splint - 00818501022564

Soft-Form™ AL External Nasal Splint, Large
INVOTEC INTERNATIONAL, INC.
20-10221
In Commercial Distribution

  • 10818501022561 ()
  • 00818501022564 ()
20-10221

  • External nasal splint

Soft-Form™ ALD External Nasal Splint - 00818501022557

Soft-Form™ ALD External Nasal Splint, Large
INVOTEC INTERNATIONAL, INC.
20-10321
In Commercial Distribution

  • 10818501022554 ()
  • 00818501022557 ()
20-10321

  • External nasal splint

Soft-Form™ ALD External Nasal Splint - 00818501022540

Soft-Form™ ALD External Nasal Splint, Regular
INVOTEC INTERNATIONAL, INC.
20-10311
In Commercial Distribution

  • 10818501022547 ()
  • 00818501022540 ()
20-10311

  • External nasal splint

Soft-Form™ ALD External Nasal Splint - 00818501022533

Soft-Form™ ALD External Nasal Splint, Small
INVOTEC INTERNATIONAL, INC.
20-10301
In Commercial Distribution

  • 10818501022530 ()
  • 00818501022533 ()
20-10301

  • External nasal splint

Soft-Form™ ALD External Nasal Splint - 00818501022526

Soft-Form™ ALD External Nasal Splint, Small
INVOTEC INTERNATIONAL, INC.
20-10300
In Commercial Distribution

  • 10818501022523 ()
  • 00818501022526 ()
  • 20818501022520 ()
20-10300

  • External nasal splint

Soft-Form™ ALD External Nasal Splint - 00818501022519

Soft-Form™ ALD External Nasal Splint, Regular
INVOTEC INTERNATIONAL, INC.
20-10310
In Commercial Distribution

  • 10818501022516 ()
  • 00818501022519 ()
  • 20818501022513 ()
20-10310

  • External nasal splint

Soft-Form™ ALD External Nasal Splint - 00818501022502

Soft-Form™ ALD External Nasal Splint, Large
INVOTEC INTERNATIONAL, INC.
20-10320
In Commercial Distribution

  • 10818501022509 ()
  • 00818501022502 ()
  • 20818501022506 ()
20-10320

  • External nasal splint

Soft-Form™ AL External Nasal Splint - 00818501022496

Soft-Form™ AL External Nasal Splint, Large
INVOTEC INTERNATIONAL, INC.
20-10220
In Commercial Distribution

  • 10818501022493 ()
  • 00818501022496 ()
20-10220

  • External nasal splint

Soft-Form™ AL External Nasal Splint - 00818501022489

Soft-Form™ AL External Nasal Splint, Regular
INVOTEC INTERNATIONAL, INC.
20-10210
In Commercial Distribution

  • 10818501022486 ()
  • 00818501022489 ()
20-10210

  • External nasal splint

Soft-Form™ AL External Nasal Splint - 00818501022472

Soft-Form™ AL External Nasal Splint, Small
INVOTEC INTERNATIONAL, INC.
20-10200
In Commercial Distribution

  • 10818501022479 ()
  • 00818501022472 ()
20-10200

  • External nasal splint

LHB Industries - 00009235421925

Male External Catheter, Wide Band, Large 36mm
The Lighthouse For The Blind
Wide Band Large
In Commercial Distribution

  • 00009235421925 ()
2204053

  • Urinary incontinence penis sheath/port, single-use

LHB Industries - 00009235421901

Male External Catheter, Wide Band, Medium 29mm
The Lighthouse For The Blind
Wide Band Medium
In Commercial Distribution

  • 00009235421901 ()
22040051

  • Urinary incontinence penis sheath/port, single-use

LHB Industries - 00009235421802

Male External Catheter, Small 25mm, Non Latex
The Lighthouse For The Blind
Ultra Flex Small
In Commercial Distribution

  • 00009235421802 ()
2204038

  • Urinary incontinence penis sheath/port, single-use

LHB Industries - 00009235421918

Male External Catheter, Wide Band, Intermediate 32mm
The Lighthouse For The Blind
Wide Band Intermed
In Commercial Distribution

  • 00009235421918 ()
2204052

  • Urinary incontinence penis sheath/port, single-use

LHB Industries - 00009235421895

Male External Catheter, Wide Band, Small 25mm
The Lighthouse For The Blind
Wide Band Small
In Commercial Distribution

  • 00009235421895 ()
2204050

  • Urinary incontinence penis sheath/port, single-use

LHB Industries - 00009235421888

Male External Catheter, X-Large 41mm, Non Latex
The Lighthouse For The Blind
Ultra Flex XL
In Commercial Distribution

  • 00009235421888 ()
2204046

  • Urinary incontinence penis sheath/port, single-use

LHB Industries - 00009235421864

Male External Catheter, Large 36mm, Non Latex
The Lighthouse For The Blind
Ultra Flex Large
In Commercial Distribution

  • 00009235421864 ()
2204044

  • Urinary incontinence penis sheath/port, single-use

LHB Industries - 00009235421840

Male External Catheter, Intermediate 32mm, Non Latex
The Lighthouse For The Blind
Ultra Flex Intermed
In Commercial Distribution

  • 00009235421840 ()
2204042

  • Urinary incontinence penis sheath/port, single-use

LHB Industries - 00009235421826

Male External Catheter, Medium 29mm, Non Latex
The Lighthouse For The Blind
Ultra Flex Medium
In Commercial Distribution

  • 00009235421826 ()
2204040

  • Urinary incontinence penis sheath/port, single-use

NA - 08717213053717

Oncentra External Beam 4.5.3/Oncentra Brachy v4.6
Nucletron B.V.
170538-00
In Commercial Distribution

  • 08717213053717 ()


  • Radiation therapy software

NA - 08717213053700

Oncentra External Beam 4.5.3/Oncentra Brachy v4.6
Nucletron B.V.
170018-00
In Commercial Distribution

  • 08717213053700 ()
  • 08717213054004 ()
  • 08717213053991 ()


  • Radiation therapy software

Sterling Washers - 10841736110512

Sterling P1500 printer, external w/o condenser
SKYTRON LLC
P1500-WO
In Commercial Distribution

  • 10841736110512 ()
P1500-WO

  • Surgical instrument washer/disinfector (chemical/thermal)

SRG-ER - 08800021124110

Screw Remover Guide ER(External Regular) IMPLANT-RESCUE-EXT-R
MCT Bio
SRG-ER
In Commercial Distribution

  • 08800021124110 ()
SRG-ER

  • Fixture/appliance dental drill bit, reusable
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