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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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StageOne™ - 00887868543180

No Description
Biomet Orthopedics, LLC
431406
In Commercial Distribution

  • 00887868543180 ()

  • Ø6mm Stem Ø46mm Head 42mm Head Width 18mm Head Thickness
431406

  • Orthopaedic cement spacer mould

CVS - 00050428447772

CVS Biodegradable Glove - One size fit all.
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
460866
In Commercial Distribution

  • 10842942016759 ()
  • 00050428447772 ()
  • 00842942016752 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

CUSTOMED - M20890022201

SURGICAL MASK BLUE, VISOR, ANTI-FOG, AQUA WITH TIES, 160MM HG
CUSTOMED INC
712057462220
In Commercial Distribution

  • M20890022201 ()
  • M20890022200 ()
  • M20890022202 ()

  • LEVEL 3 BARRIER PROTECTION 160 MM HG
9002220

  • Surgical/medical face mask, single-use

CUSTOMED - M20890022151

PROCEDURE MASK, VISOR, ANTI-FOG, AQUA WITH EAR LOOPS, 160MM HG
CUSTOMED INC
712057462215
In Commercial Distribution

  • M20890022151 ()
  • M20890022150 ()
  • M20890022152 ()

  • LEVEL 3 BARRIER PROTECTION 160 MM HG
9002215

  • Surgical/medical face mask, single-use

CUSTOMED - M20890022131

SURGICAL MASK, ANTI-FOG ADHESIVE TAPE, GREEN 80MM HG
CUSTOMED INC
712057462213
In Commercial Distribution

  • M20890022131 ()
  • M20890022130 ()
  • M20890022132 ()

  • LEVEL 1 BARRIER PROTECTION 80 MM HG
9002213

  • Surgical/medical face mask, single-use

EM 15 Blood Glucose Level 2 Control Solution - 00885017000638

a bottle of level 2 control solution
EPS BIO TECHNOLOGY CORP.
EM44
In Commercial Distribution

  • 10885017000635 ()
  • 00885017000638 ()


  • Glucose IVD, control

EasyMax Blood Glucose Level 2 Control Solution - 00885017000591

1 bottle of Level 2 Control Solution
EPS BIO TECHNOLOGY CORP.
EasyMax
In Commercial Distribution

  • 00885017000591 ()
  • 01885017000590 ()
  • 10885017000598 ()


  • Glucose IVD, control

EM 15 Blood Glucose Level 1 and Level 2 Control Solution - 00885017000584

a bottle of level 1 and a bottle of level 2 control solution
EPS BIO TECHNOLOGY CORP.
EM44
In Commercial Distribution

  • 00885017000584 ()
  • 10885017000581 ()


  • Glucose IVD, control

EasyMax 15 NHCS Set EN - 00885017000560

a bottle of level 2 control solution
EPS BIO TECHNOLOGY CORP.
EM44
In Commercial Distribution

  • 10885017000567 ()
  • 00885017000560 ()


  • Glucose IVD, control

EasyMax NHCS Set EN - 00885017000553

1 bottle of Level 2 Solution
EPS BIO TECHNOLOGY CORP.
EasyMax
In Commercial Distribution

  • 10885017000550 ()
  • 00885017000553 ()


  • Glucose IVD, control

FortisCare Self-Monitoring Blood Glucose System - 00885017000461

1 blood glucose meter; 10 strips in a vial; level 2 control solution in a convenience kit
EPS BIO TECHNOLOGY CORP.
EM66
Not in Commercial Distribution

  • 00885017000461 ()
  • 01885017000460 ()
  • 10885017000468 ()


  • Glucose monitoring system IVD, home-use

FortisCare Blood Glucose Test Strip - 00885017000447

50 strips in a vial
EPS BIO TECHNOLOGY CORP.
EM44
Not in Commercial Distribution

  • 00885017000447 ()
  • 01885017000446 ()


  • Glucose IVD, kit, electrometry

EasyMax 15 Blood Glucose Test Strip - 00885017000416

50 strips in a vial
EPS BIO TECHNOLOGY CORP.
EM44
In Commercial Distribution

  • 00885017000416 ()
  • 01885017000415 ()
  • 10885017000413 ()


  • Glucose IVD, kit, enzyme spectrophotometry, rapid

EASYMAX T1 Self-Monitoring Blood Glucose System - 00885017000409

1 blood glucose meter; 25 ct. Foiled Pack Test Strips; 10 Lancets, 1 Lancing device in a convenience kit.
EPS BIO TECHNOLOGY CORP.
EasyMax T1 Pro
In Commercial Distribution

  • 00885017000409 ()
  • 10885017000406 ()


  • Glucose monitoring system IVD, home-use

EM 15 Blood Glucose Level 1 Control Solution - 00885017000362

a bottle of level 1 control solution
EPS BIO TECHNOLOGY CORP.
EM44
In Commercial Distribution

  • 00885017000362 ()
  • 01885017000361 ()


  • Glucose IVD, control

EasyMax Blood Glucose Test Strip - 00885017000355

10 strips in a vial
EPS BIO TECHNOLOGY CORP.
EasyMax
In Commercial Distribution

  • 00885017000355 ()
  • 01885017000354 ()
  • 10885017000352 ()


  • Glucose IVD, kit, electrometry

EasyMax NG Self-Monitoring Blood Glucose System - 00885017000324

1 blood glucose meter; 10 strips in a vial; level 2 control solution, 10 lancets, 1 lancing device in a convenience kit. 1 blood glucose meter; 10 strips in a vial; level 2 control solution, 5 lancets, 1 lancing device in a convenience kit. (10885017000321)
EPS BIO TECHNOLOGY CORP.
EMMU
In Commercial Distribution

  • 00885017000324 ()
  • 01885017000323 ()
  • 10885017000321 ()


  • Glucose monitoring system IVD, home-use

25 EasyMax 15 FTS Set EN-ES - 00885017000287

The EASY MAX 15 Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, or forearm. The test Strips must be used with the EASY MAX 15 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, is not for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can only be used during steady-state blood glucose conditions.
EPS BIO TECHNOLOGY CORP.
EASY MAX 15
In Commercial Distribution

  • 10885017000284 ()
  • 00885017000287 ()


  • Glucose IVD, kit, enzyme spectrophotometry, rapid

25 EasyMax FTS Set EN-ES - 00885017000270

The EASY MAX Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. The EASY MAX Glucose Test Strips must be used with the EASY MAX Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
EPS BIO TECHNOLOGY CORP.
EASY MAX
In Commercial Distribution

  • 10885017000277 ()
  • 00885017000270 ()


  • Glucose IVD, kit, enzyme spectrophotometry, rapid

EasyMax 15 Blood Glucose Test Strip - 00885017000171

10 strips in a vial
EPS BIO TECHNOLOGY CORP.
EM44
In Commercial Distribution

  • 01885017000170 ()
  • 00885017000171 ()
  • 10885017000178 ()


  • Glucose IVD, kit, electrometry

EasyMax LTC Self-Monitoring Blood Glucose System - 00885017000102

Semi kit: one blood glucose meter
EPS BIO TECHNOLOGY CORP.
EMMU
In Commercial Distribution

  • 01885017000101 ()
  • 00885017000102 ()
  • 10885017000109 ()


  • Glucose monitoring system IVD, home-use

EasyMax NG Self-Monitoring Blood Glucose System - 00885017000065

Semi kit: one blood glucose meter
EPS BIO TECHNOLOGY CORP.
EMMU
In Commercial Distribution

  • 00885017000065 ()
  • 01885017000064 ()
  • 10885017000062 ()


  • Glucose monitoring system IVD, home-use

EasyMax V Self-Monitoring Blood Glucose System - 00885017000058

one blood glucose meter
EPS BIO TECHNOLOGY CORP.
EMV
In Commercial Distribution

  • 00885017000058 ()
  • 01885017000057 ()
  • 10885017000055 ()


  • Glucose monitoring system IVD, home-use

EasyMax Blood Glucose Test Strip - 00885017000010

50 strips in a vial
EPS BIO TECHNOLOGY CORP.
EasyMax
In Commercial Distribution

  • 00885017000010 ()
  • 01885017000019 ()
  • 10885017000017 ()


  • Glucose IVD, kit, electrometry

NA - 00385640025607

No Description
Summit Medical, Inc.
SP-27015-01
In Commercial Distribution

  • 00385640025607 ()
  • 10385640025604 ()


  • Intranasal splint, non-biodegradable

OSSEOUS Thermoplastic Splint Kit - 08906039316506

External Thermoplastic Nasal Splint splinting of nasal dorsum after Rhinoplastly and providing support of nasal Septal structure.
EON MEDITECH PRIVATE LIMITED
E5150K
In Commercial Distribution

  • 08904461000963 ()
  • 08906039316506 ()
  • 08904428745302 ()


  • External nasal splint

OSSEOUS Aluminium Splint Kit - 08906039316490

External Aluminium Nasal Splint splinting of nasal dorsum after Rhinoplastly and providing support of nasal septal structure.
EON MEDITECH PRIVATE LIMITED
E6149K
In Commercial Distribution

  • 08904428745319 ()
  • 08906039316490 ()
  • 08904461009164 ()


  • External nasal splint

OSSEOUS Internal Nasal Bi-valve Splint - Thin Pediatric - 08906039315486

Fluoroplastic Internal Nasal Splint enhances patient comfort by allowing nasal breathing while providing support of nasal septal structure.
EON MEDITECH PRIVATE LIMITED
E3148FTP
In Commercial Distribution

  • 08906039311914 ()
  • 08906039315486 ()

  • Length: 42 Millimeter
  • Width: 27 Millimeter
  • Height: 0.25 Millimeter


  • Intranasal splint, non-biodegradable

OSSEOUS Internal Nasal Bi-valve Splint - Standard Pediatric - 08906039314489

Fluoroplastic Internal Nasal Splint enhances patient comfort by allowing nasal breathing while providing support of nasal septal structure.
EON MEDITECH PRIVATE LIMITED
E3148FSP
In Commercial Distribution

  • 08906039311907 ()
  • 08906039314489 ()

  • Length: 42 Millimeter
  • Width: 27 Millimeter
  • Height: 0.50 Millimeter


  • Intranasal splint, non-biodegradable

OSSEOUS Internal Nasal Bi-valve Splint - Thin - 08906039313482

Fluoroplastic Internal Nasal Splint enhances patient comfort by allowing nasal breathing while providing support of nasal septal structure.
EON MEDITECH PRIVATE LIMITED
E3148FT
In Commercial Distribution

  • 08906039311891 ()
  • 08906039313482 ()

  • Length: 60.00 Millimeter
  • Width: 38.00 Millimeter
  • Height: 0.25 Millimeter


  • Intranasal splint, non-biodegradable

OSSEOUS External Aluminium Splints - 08906039312492

External Aluminium Nasal Splint splinting of nasal dorsum after Rhinoplastly and providing support of nasal septal structure.
EON MEDITECH PRIVATE LIMITED
E6149L
In Commercial Distribution

  • 08906039312621 ()
  • 08906039312492 ()
  • 08904428745289 ()

  • Length: 45 Millimeter
  • Width: 66.88 Millimeter
  • Width: 38.74 Millimeter
  • Height: 0.6 Millimeter


  • External nasal splint

OSSEOUS Internal Nasal Bi-valve Splint - Standard - 08906039312485

Fluoroplastic Internal Nasal Splint enhances patient comfort by allowing nasal breathing while providing support of nasal septal structure.
EON MEDITECH PRIVATE LIMITED
E3148FS
In Commercial Distribution

  • 08906039311884 ()
  • 08906039312485 ()

  • Length: 60.00 Millimeter
  • Width: 38.00 Millimeter
  • Height: 0.50 Millimeter


  • Intranasal splint, non-biodegradable

OSSEOUS Internal Nasal Pre-Cut Splint - 08906039312478

"Internal Nasal Splint enhances patient comfort by Allowing nasal breathing while providing support of nasal Septal structure. "
EON MEDITECH PRIVATE LIMITED
E3147P
In Commercial Distribution

  • 08906039311686 ()
  • 08906039312478 ()

  • Length: 70.00 Millimeter
  • Width: 25.00 Millimeter
  • Height: 1.00 Millimeter


  • Intranasal splint, non-biodegradable

OSSEOUSExternal Thermoplastic Splint - 08906039311501

External Thermoplastic Nasal Splint splinting of nasal dorsum after Rhinoplastly and providing support of nasal Septal structure.
EON MEDITECH PRIVATE LIMITED
E5150M
In Commercial Distribution

  • 08906039312416 ()
  • 08906039311501 ()
  • 08906039312386 ()

  • Length: 38 Millimeter
  • Width: 60 Millimeter
  • Width: 40 Millimeter
  • Height: 1.9 Millimeter


  • External nasal splint

OSSEOUS External Aluminium Splints - 08906039311495

External Aluminium Nasal Splint splinting of nasal dorsum after Rhinoplastly and providing support of nasal septal structure.
EON MEDITECH PRIVATE LIMITED
E6149M
In Commercial Distribution

  • 08906039312553 ()
  • 08906039311495 ()
  • 08906039310511 ()

  • Length: 40 Millimeter
  • Width: 59.93 Millimeter
  • Width: 35.73 Millimeter
  • Height: 0.6 Millimeter


  • External nasal splint

OSSEOUS Internal Nasal Bi-valve Splint - Thick - 08906039311488

"Internal Nasal Splint enhances patient comfort by Allowing nasal breathing while providing support of nasal Septal structure. "
EON MEDITECH PRIVATE LIMITED
E3148ST
In Commercial Distribution

  • 08906039311877 ()
  • 08906039311488 ()

  • Length: 60.00 Millimeter
  • Width: 38.00 Millimeter
  • Height: 1.00 Millimeter


  • Intranasal splint, non-biodegradable

OSSEOUS Internal Nasal Airways Splint - Large - 08906039311471

"Internal Nasal Splint enhances patient comfort by Allowing nasal breathing while providing support of nasal Septal structure. "
EON MEDITECH PRIVATE LIMITED
E3147L
In Commercial Distribution

  • 08906039311679 ()
  • 08906039311471 ()

  • Length: 84.50 Millimeter
  • Width: 40.00 Millimeter
  • Height: 1.00 Millimeter


  • Intranasal splint, non-biodegradable

OSSEOUS Silicone Block - 08906039310726

"Internal Nasal Splint enhances patient comfort by Allowing nasal breathing while providing support of nasal Septal structure. "
EON MEDITECH PRIVATE LIMITED
E3146BM
In Commercial Distribution

  • 08904428745265 ()
  • 08906039310726 ()

  • Length: 6 Centimeter
  • Width: 4 Centimeter
  • Height: 1.5 Centimeter


  • Silicone-sheet tissue reconstructive material

OSSEOUS Silicone Block - 08906039310719

"Internal Nasal Splint enhances patient comfort by Allowing nasal breathing while providing support of nasal Septal structure. "
EON MEDITECH PRIVATE LIMITED
E3146BS
In Commercial Distribution

  • 08904428745258 ()
  • 08906039310719 ()

  • Length: 5 Centimeter
  • Width: 3 Centimeter
  • Height: 1 Centimeter


  • Silicone-sheet tissue reconstructive material

OSSEOUS Silicone Sheets - 08906039310603

"Internal Nasal Splint enhances patient comfort by Allowing nasal breathing while providing support of nasal Septal structure. "
EON MEDITECH PRIVATE LIMITED
E3146NS
In Commercial Distribution

  • 08906039311662 ()
  • 08906039310603 ()

  • Height: 1 Millimeter


  • Silicone-sheet tissue reconstructive material

OSSEOUS Silicone Sheets - 08906039310597

"Internal Nasal Splint enhances patient comfort by Allowing nasal breathing while providing support of nasal Septal structure. "
EON MEDITECH PRIVATE LIMITED
E3146MS
In Commercial Distribution

  • 08906039311655 ()
  • 08906039310597 ()

  • Height: 0.5 Millimeter


  • Silicone-sheet tissue reconstructive material

OSSEOUS Silicone Sheets - 08906039310580

"Internal Nasal Splint enhances patient comfort by Allowing nasal breathing while providing support of nasal Septal structure. "
EON MEDITECH PRIVATE LIMITED
E3146US
In Commercial Distribution

  • 08906039311648 ()
  • 08906039310580 ()

  • Height: 0.25 Millimeter


  • Silicone-sheet tissue reconstructive material

OSSEOUS Silicone Sheets - 08906039310573

"Internal Nasal Splint enhances patient comfort by Allowing nasal breathing while providing support of nasal Septal structure. "
EON MEDITECH PRIVATE LIMITED
E3146UUS
In Commercial Distribution

  • 08906039311631 ()
  • 08906039310573 ()

  • Height: 0.13 Millimeter


  • Silicone-sheet tissue reconstructive material

OSSEOUS Silicone Sheets - 08906039310566

"Internal Nasal Splint enhances patient comfort by Allowing nasal breathing while providing support of nasal Septal structure. "
EON MEDITECH PRIVATE LIMITED
E3146T
In Commercial Distribution

  • 08906039311624 ()
  • 08906039310566 ()

  • Height: 5 Millimeter


  • Silicone-sheet tissue reconstructive material

OSSEOUSExternal Thermoplastic Splint - 08906039310504

External Thermoplastic Nasal Splint splinting of nasal dorsum after Rhinoplastly and providing support of nasal Septal structure.
EON MEDITECH PRIVATE LIMITED
E5150S
In Commercial Distribution

  • 08906039312409 ()
  • 08906039310504 ()
  • 08906039312379 ()

  • Length: 33 Millimeter
  • Width: 55 Millimeter
  • Width: 35 Millimeter
  • Height: 1.9 Millimeter


  • External nasal splint

OSSEOUS External Aluminium Splints - 08906039310498

External Aluminium Nasal Splint splinting of nasal dorsum after Rhinoplastly and providing support of nasal septal structure.
EON MEDITECH PRIVATE LIMITED
E6149S
In Commercial Distribution

  • 08906039310498 ()
  • 08906039312515 ()
  • 08906039310443 ()

  • Width: 56.91 Millimeter
  • Width: 37.73 Millimeter
  • Height: 0.6 Millimeter
  • Length: 33 Millimeter


  • External nasal splint

OSSEOUS Internal Nasal Bi-valve Splint - Standard(Silicone) - 08906039310481

"Internal Nasal Splint enhances patient comfort by Allowing nasal breathing while providing support of nasal Septal structure. "
EON MEDITECH PRIVATE LIMITED
E3148SS
In Commercial Distribution

  • 08906039311693 ()
  • 08906039310481 ()

  • Length: 60.00 Millimeter
  • Width: 38.00 Millimeter
  • Height: 0.50 Millimeter


  • Intranasal splint, non-biodegradable

OSSEOUS Internal Nasal Airways Splint - Standard - 08906039310474

"Internal Nasal Splint enhances patient comfort by Allowing nasal breathing while providing support of nasal Septal structure. "
EON MEDITECH PRIVATE LIMITED
E3147S
In Commercial Distribution

  • 08906039310436 ()
  • 08906039310474 ()

  • Length: 70 Millimeter
  • Width: 25 Millimeter
  • Height: 1 Millimeter


  • Intranasal splint, non-biodegradable

OSSEOUS Silicone Sheets - 08906039310467

"Internal Nasal Splint enhances patient comfort by Allowing nasal breathing while providing support of nasal Septal structure. "
EON MEDITECH PRIVATE LIMITED
E3146S
In Commercial Distribution

  • 08906039311617 ()
  • 08906039310467 ()

  • Height: 3 Millimeter


  • Silicone-sheet tissue reconstructive material

OSSEOUS Fluoroplastic Sheet - 08904461000109

Fluoroplastic Internal Nasal Splint enhances patient comfort by allowing nasal breathing while providing support of nasal septal structure.
EON MEDITECH PRIVATE LIMITED
E3146MSF
In Commercial Distribution

  • 08904461000079 ()
  • 08904461000109 ()

  • Height: 0.5 Millimeter


  • Silicone-sheet tissue reconstructive material
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