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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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Medline Industries, Inc. - 10889942214518

ROBOTIC LAP CHOLE
MEDLINE INDUSTRIES, INC.
DYNJ901282D
In Commercial Distribution

  • 40889942214519 ()
  • 10889942214518 ()
DYNJ901282D

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942214501

ROBOTIC PACK
MEDLINE INDUSTRIES, INC.
DYNJ51819
In Commercial Distribution

  • 10889942214501 ()
DYNJ51819

  • General surgical procedure kit, non-medicated, reusable

Verifine - 00850011833605

Blood Lancet is a sterile, handheld, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider or patient self to manually puncture the skin to obtain a small blood specimen.
Promisemed Medical Devices Inc.
BL-28G
In Commercial Distribution

  • 80850011833601 ()
  • 00850011833605 ()
  • 10850011833602 ()


  • Blood lancet, single-use

Verifine - 00850011833568

The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement. This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-7053008-100
In Commercial Distribution

  • 10850011833565 ()
  • 00850011833568 ()
  • 80850011833564 ()


  • Insulin syringe/needle, basic

Verifine - 00850011833551

The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement. This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-7033108-100
In Commercial Distribution

  • 10850011833558 ()
  • 00850011833551 ()
  • 80850011833557 ()


  • Insulin syringe/needle, basic

Verifine - 00850011833537

Safety lancet is sterile, single use, spring loaded lancets designed for capillary blood sampling. These lancets are precision sharpened designed for maximum comfort and optimal blood flow. Safety lancets are designed to make taking a blood sample simple and easy. Safety lancets are activated when you press the device against your finger. Once activated the needle retracts into the body of the device which reduces the risk of injury as the result if an exposed needle. The first spring releases the needle into the skin and the second withdraws the needle back into the shield.
Promisemed Medical Devices Inc.
SL-3018T
In Commercial Distribution

  • 10850011833534 ()
  • 00850011833537 ()
  • 80850011833533 ()


  • Blood lancet, single-use

Verifine - 00850011833506

Blood Lancet is a sterile, handheld, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider or patient self to manually puncture the skin to obtain a small blood specimen.
Promisemed Medical Devices Inc.
BL-30G
In Commercial Distribution

  • 10850011833503 ()
  • 00850011833506 ()
  • 80850011833502 ()


  • Blood lancet, single-use

Verifine - 00850011833490

The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. Different models are distinguished by needle gauge and length.
Promisemed Medical Devices Inc.
IPN-31-04
In Commercial Distribution

  • 10850011833497 ()
  • 00850011833490 ()
  • 80850011833496 ()


  • Autoinjector needle

Verifine - 00850011833483

The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. Different models are distinguished by needle gauge and length.
Promisemed Medical Devices Inc.
IPN-29-12
In Commercial Distribution

  • 10850011833480 ()
  • 00850011833483 ()
  • 80850011833489 ()


  • Autoinjector needle

Verifine - 00850011833445

Blood Lancet is a sterile, handheld, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider or patient self to manually puncture the skin to obtain a small blood specimen.
Promisemed Medical Devices Inc.
BL-33G
In Commercial Distribution

  • 10850011833442 ()
  • 00850011833445 ()
  • 80850011833441 ()


  • Blood lancet, single-use

Verifine - 00850011833438

The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. Different models are distinguished by needle gauge and length.
Promisemed Medical Devices Inc.
IPN-31-08
In Commercial Distribution

  • 10850011833435 ()
  • 00850011833438 ()
  • 80850011833434 ()


  • Autoinjector needle

Verifine - 00850011833421

The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. Different models are distinguished by needle gauge and length.
Promisemed Medical Devices Inc.
IPN-31-05
In Commercial Distribution

  • 10850011833428 ()
  • 00850011833421 ()
  • 80850011833427 ()


  • Autoinjector needle

Verifine - 00850011833278

The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. Different models are distinguished by needle gauge and length.
Promisemed Medical Devices Inc.
IPN-33-04
In Commercial Distribution

  • 10850011833275 ()
  • 00850011833278 ()
  • 80850011833274 ()


  • Autoinjector needle

Verifine - 00850011833261

The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. Different models are distinguished by needle gauge and length.
Promisemed Medical Devices Inc.
IPN-32-06
In Commercial Distribution

  • 10850011833268 ()
  • 00850011833261 ()
  • 80850011833267 ()


  • Autoinjector needle

Verifine - 00850011833254

The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. Different models are distinguished by needle gauge and length.
Promisemed Medical Devices Inc.
IPN-32-05
In Commercial Distribution

  • 10850011833251 ()
  • 00850011833254 ()
  • 80850011833250 ()


  • Autoinjector needle

Verifine - 00850011833247

The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. Different models are distinguished by needle gauge and length.
Promisemed Medical Devices Inc.
IPN-31-06
In Commercial Distribution

  • 10850011833244 ()
  • 00850011833247 ()
  • 80850011833243 ()


  • Autoinjector needle

Verifine - 00850011833230

Safety lancet is sterile, single use, spring loaded lancets designed for capillary blood sampling. These lancets are precision sharpened designed for maximum comfort and optimal blood flow. Safety lancets are designed to make taking a blood sample simple and easy. Safety lancets are activated when you press the device against your finger. Once activated the needle retracts into the body of the device which reduces the risk of injury as the result if an exposed needle. The first spring releases the needle into the skin and the second withdraws the needle back into the shield.
Promisemed Medical Devices Inc.
SL-2124M
In Commercial Distribution

  • 10850011833237 ()
  • 00850011833230 ()
  • 80850011833236 ()


  • Blood lancet, single-use

Verifine - 00850011833209

Safety lancet is sterile, single use, spring loaded lancets designed for capillary blood sampling. These lancets are precision sharpened designed for maximum comfort and optimal blood flow. Safety lancets are designed to make taking a blood sample simple and easy. Safety lancets are activated when you press the device against your finger. Once activated the needle retracts into the body of the device which reduces the risk of injury as the result if an exposed needle. The first spring releases the needle into the skin and the second withdraws the needle back into the shield.
Promisemed Medical Devices Inc.
SL-2118M
In Commercial Distribution

  • 10850011833206 ()
  • 00850011833209 ()
  • 80850011833205 ()


  • Blood lancet, single-use

Verifine - 00850011833131

Safety lancet is sterile, single use, spring loaded lancets designed for capillary blood sampling. These lancets are precision sharpened designed for maximum comfort and optimal blood flow. Safety lancets are designed to make taking a blood sample simple and easy. Safety lancets are activated when you press the device against your finger. Once activated the needle retracts into the body of the device which reduces the risk of injury as the result if an exposed needle. The first spring releases the needle into the skin and the second withdraws the needle back into the shield.
Promisemed Medical Devices Inc.
SL-3018M
In Commercial Distribution

  • 10850011833138 ()
  • 00850011833131 ()
  • 80850011833137 ()


  • Blood lancet, single-use

Verifine - 00850011833049

The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. Different models are distinguished by needle gauge and length.
Promisemed Medical Devices Inc.
IPN-32-04
In Commercial Distribution

  • 10850011833046 ()
  • 00850011833049 ()
  • 80850011833045 ()


  • Autoinjector needle

Pillow Passive Driver Kit - 00850011790229

No Description
RESOUNDANT, INC.
REFDAUX
In Commercial Distribution

  • 00850011790229 ()


  • Magnetic resonance elastography acoustic driver

Hepatogram Plus - 00850011790199

No Description
RESOUNDANT, INC.
3.0DKR
In Commercial Distribution

  • 00850011790199 ()
MREPLUSV3

  • MRI system application software

Active Driver - 00850011790168

No Description
RESOUNDANT, INC.
RESYS4001
In Commercial Distribution

  • 00850011790168 ()


  • Magnetic resonance elastography acoustic driver

MR Elastography System - 00850011790151

No Description
RESOUNDANT, INC.
RESYS4001-RESYSAB
In Commercial Distribution

  • 00850011790151 ()


  • Magnetic resonance elastography acoustic driver

Passive Driver - 00850011790106

No Description
RESOUNDANT, INC.
REPD2000
In Commercial Distribution

  • 00850011790106 ()


  • Magnetic resonance elastography acoustic driver

Flex Passive Driver Kit- Small - 00850011790052

No Description
RESOUNDANT, INC.
REFPDS19
In Commercial Distribution

  • 00850011790052 ()


  • Magnetic resonance elastography acoustic driver

Flex Passive Driver Kit- Large - 00850011790045

No Description
RESOUNDANT, INC.
REFPDL18
In Commercial Distribution

  • 00850011790045 ()


  • Magnetic resonance elastography acoustic driver

Resoundant Acoustic Driver System - 00850011790021

No Description
RESOUNDANT, INC.
RESY3002-RESYSAB
In Commercial Distribution

  • 00850011790021 ()


  • Magnetic resonance elastography acoustic driver

MREplus - 00850011790014

No Description
RESOUNDANT, INC.
MREplus 3.0.0WIN
Not in Commercial Distribution

  • 00850011790014 ()


  • MRI system application software

MREplus - 00850011790007

No Description
RESOUNDANT, INC.
MREplus 3.0.0DKR
Not in Commercial Distribution

  • 00850011790007 ()


  • MRI system application software

MedLite ID - 00850011772003

MedLite ID
Medlite ID
IDA01-CR
In Commercial Distribution

  • 00850011772010 ()
  • 00850011772003 ()


  • Intravenous line identification light

Wrench, Helical Drive, ML7 - 00850011743997

Wrench use to adjust helical screw on the ML7 Vacuum Rings
MED LOGICS INC
1350ML7
In Commercial Distribution

  • 00850011743997 ()
1350ML7

  • Microkeratome

OSTEO-Derm Enhanced - 00850011613160

Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
OSTEODE30x40
In Commercial Distribution

  • 00850011613160 ()

  • 30mm x 40mm


  • Collagen dental regeneration membrane

OSTEO-Derm Enhanced - 00850011613153

Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
OSTEODE20x30
In Commercial Distribution

  • 00850011613153 ()

  • 20mm x 30mm


  • Collagen dental regeneration membrane

OSTEO-Derm Enhanced - 00850011613146

Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
OSTEODE15x20
In Commercial Distribution

  • 00850011613146 ()

  • 15mm x 20mm


  • Collagen dental regeneration membrane

OSTEO-Derm - 00850011613054

Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
OSTEOD30x40
In Commercial Distribution

  • 00850011613054 ()

  • 30mm x 40mm


  • Collagen dental regeneration membrane

OSTEO-Derm - 00850011613047

Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
OSTEOD20x30
In Commercial Distribution

  • 00850011613047 ()

  • 20mm x 30mm


  • Collagen dental regeneration membrane

OSTEO-Derm - 00850011613030

Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
OSTEOD15x20
In Commercial Distribution

  • 00850011613030 ()

  • 15mm x 20mm


  • Collagen dental regeneration membrane

OSTEO-Flex - 00850011613023

Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
OSTEOF30x40
In Commercial Distribution

  • 00850011613023 ()

  • 30mm x 40mm


  • Collagen dental regeneration membrane

OSTEO-Flex - 00850011613016

Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
OSTEOF20x30
In Commercial Distribution

  • 00850011613016 ()

  • 20mm x 30mm


  • Collagen dental regeneration membrane
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