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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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ACS - 00191072088574

ANGIOGRAPHY F/G
AMERICAN CONTRACT SYSTEMS, INC.
SAAN71T
In Commercial Distribution

  • 00191072088574 ()


  • General surgical procedure kit, non-medicated, single-use

Bonding Accessories - 00192029000205

Enamel Conditioner G
TP ORTHODONTICS INC
150-015
In Commercial Distribution

  • 00192029000205 ()


  • Orthodontic bracket adhesive

ACS - 00191072153456

ANGIOGRAPHY F/G
AMERICAN CONTRACT SYSTEMS, INC.
SAAN71V
In Commercial Distribution

  • 00191072153456 ()


  • General surgical procedure kit, non-medicated, single-use

ACS - 00191072127068

ANGIOGRAPHY F/G
AMERICAN CONTRACT SYSTEMS, INC.
SAAN71U
In Commercial Distribution

  • 00191072127068 ()


  • General surgical procedure kit, non-medicated, single-use

ACS - 00191072026934

ANGIOGRAPHY F/G
AMERICAN CONTRACT SYSTEMS, INC.
SAAN71R
In Commercial Distribution

  • 00191072026934 ()


  • General surgical procedure kit, non-medicated, single-use

4052 G Transporter - 00190790000547

4052 G Transporter
FERNO-WASHINGTON, INC.
0054125
Not in Commercial Distribution

  • 00190790000547 ()


  • Ambulance stretcher, manual

Millennium - 00190776196257

Lamis Cannula g
Avalign Technologies, Inc.
39-BN1235
In Commercial Distribution

  • 00190776196257 ()


  • Liposuction system cannula, reusable

ACS - 00191072178381

ANGIOGRAPHY F/G
AMERICAN CONTRACT SYSTEMS, INC.
SAAN71W
In Commercial Distribution

  • 00191072178381 ()


  • General surgical procedure kit, non-medicated, single-use

ACS - 00191072223357

ANGIOGRAPHY F/G
AMERICAN CONTRACT SYSTEMS, INC.
SAAN71X
In Commercial Distribution

  • 00191072223357 ()


  • General surgical procedure kit, non-medicated, single-use

ACS - 00191072054470

ANGIOGRAPHY F/G
AMERICAN CONTRACT SYSTEMS, INC.
SAAN71S
In Commercial Distribution

  • 00191072054470 ()


  • General surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10887488883854

G U MAJOR
Cardinal Health 200, LLC
PG5AMJKSM
In Commercial Distribution

  • 50887488883852 ()
  • 10887488883854 ()
PG5AMJKSM

  • General surgical procedure kit, medicated

KLOCKNER - 08435451601179

EC G TRANSFER
SOADCO, S.L.
10 09 02 G
In Commercial Distribution

  • 08435451601179 ()
10 09 02 G

  • Dental implant suprastructure kit

DONJOY - 00888912152341

ARCH RIVAL, G
DJO, LLC
11-2015-7
In Commercial Distribution

  • 00888912152341 ()


  • Foot orthosis

Knee Instruments - 07630971219625

G Rigid body
Medacta International SA
33.22.0003
In Commercial Distribution

  • 07630971219625 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Ceram-Bond - EBRE520003230

Ceram-Bond 7 g
bredent GmbH & Co. KG
52000323
Not in Commercial Distribution

  • EBRE520003239 ()
  • EBRE520003230 ()
52000323

  • Dental appliance fabrication material, resin

Ceram-Bond - EBRE520003220

Ceram-Bond 30 g
bredent GmbH & Co. KG
52000322
Not in Commercial Distribution

  • EBRE520003229 ()
  • EBRE520003220 ()
52000322

  • Dental appliance fabrication material, resin

Chrome-Cobalt-Bonding - EBRE520003210

Chrome-Cobalt-Bonding 4.5 g
bredent GmbH & Co. KG
52000321
Not in Commercial Distribution

  • EBRE520003219 ()
  • EBRE520003210 ()
52000321

  • Dental appliance fabrication material, resin

Chrome-Cobalt-Bonding - EBRE520003200

Chrome-Cobalt-Bonding 19 g
bredent GmbH & Co. KG
52000320
In Commercial Distribution

  • EBRE520003209 ()
  • EBRE520003200 ()
52000320

  • Dental appliance fabrication material, resin

Medline Industries, Inc. - 10198459070457

SHN G/B-NASAL-CDS-LF
MEDLINE INDUSTRIES, INC.
CDS984013D
In Commercial Distribution

  • 40198459070458 ()
  • 10198459070457 ()
CDS984013D

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10198459070396

SHN G/B-AAA-CDS-LF
MEDLINE INDUSTRIES, INC.
CDS984011D
In Commercial Distribution

  • 10198459070396 ()
CDS984011D

  • General surgical procedure kit, non-medicated, single-use

BASE - 00887517700452

BASE Guide, G
Nuvasive, Inc.
6950307
In Commercial Distribution

  • 00887517700452 ()


  • Surgical instrument/implant depth limiter, reusable

Pads - 00887761968936

Pad 215x100 G
Baxter Medical Systems GmbH + Co. KG
2080435
In Commercial Distribution

  • 00887761968936 ()


  • Operating table orthopaedic extension, non-powered

Polycril, MDC Dental - 07506338320177

POLYCRIL 454 g
MDC DENTAL
Polisher
In Commercial Distribution

  • 07506338320177 ()


  • Dental acrylic resin

BLUE AND GREEN - 00840018649101

B&G PERIOSTEAL ELEVATOR DOUBLE END G/FOX HND700
NORDENT MANUFACTURING INC
EPGF14/BG
In Commercial Distribution

  • 00840018649101 ()


  • Periosteal elevator, reusable

NeoLINER LC 1 g Kit - 00810092939276

NeoLINER LC 1 g Kit - 1 g + 15 Tips
NUSMILE, LTD.
NNLSK
In Commercial Distribution

  • 00810092939276 ()


  • Dental composite resin

SAFIRA - 05060727270068

SAFIRA System hand operator for controlling SAFIRA Driver
MEDOVATE LIMITED
SAFIRA Palm Operator
In Commercial Distribution

  • 05060727270068 ()
900059

  • Pain management medication delivery system

SAFIRA - 05060727270037

Sterile SAFIRA 20 mL syringe (Luer)
MEDOVATE LIMITED
SAFIRA Syringe
In Commercial Distribution

  • 35060727270038 ()
  • 05060727270037 ()
900016

  • Pain management medication delivery system

SAFIRA - 05060727270013

SAFIRA system foot operator for controlling SAFIRA Driver
MEDOVATE LIMITED
SAFIRA Foot Pedal
In Commercial Distribution

  • 05060727270013 ()
900044

  • Pain management medication delivery system

SAFIRA - 05060727270051

Sterile SAFIRA 20 mL syringe (NRFit)
MEDOVATE LIMITED
SAFIRA NRFit Syringe
In Commercial Distribution

  • 35060727270052 ()
  • 05060727270051 ()
900058

  • Pain management medication delivery system

SAFIRA - 05060727270020

SAFIRA Driver unit that injects/aspirates works in combination with SAFIRA operators and SAFIRA Syringes
MEDOVATE LIMITED
SAFIRA Driver
In Commercial Distribution

  • 05060727270020 ()
900029

  • Pain management medication delivery system

Hands Free Syringe - 00850316008036

Hands Free Syringe reusable foot pedal, 1 unit per box
BLUEFIN MEDICAL LLC
HFS-PDL
In Commercial Distribution

  • 00850316008036 ()
412072-001

  • Pain management medication delivery system

Hands Free Syringe - 00850316008029

Hands Free Syringe limited reuse motor housing, 1 unit per box
BLUEFIN MEDICAL LLC
HFS-HOU
In Commercial Distribution

  • 00850316008029 ()
412071-001

  • Pain management medication delivery system

Hands Free Syringe - 00850316008005

Hands Free Syringe single-use sterile syringe
BLUEFIN MEDICAL LLC
HFS-SYR
In Commercial Distribution

  • 00850316008012 ()
  • 00850316008005 ()
412073-001

  • Pain management medication delivery system

Human IgG, IgA, IgM ‘NL’ BINDARID™ COMBI RID Kit - 05051700010368

No Description
THE BINDING SITE GROUP LIMITED
RK002
Not in Commercial Distribution

  • 05051700010368 ()


  • Total immunoglobulin M (IgM total) IVD, antibody
  • Total immunoglobulin A (IgA total) IVD, antibody
  • Total immunoglobulin G (IgG total) IVD, antibody

STRADIS HEALTHCARE - M75257032370

No Description
STRADIS MEDICAL, LLC
570-3237
In Commercial Distribution

  • M75257032370 ()


  • Pain management medication delivery system

Hands Free Syringe - 00814384020413

1 Motor Housing unit that injects/aspirates the HFS Sterile Syringe
CONCERT MEDICAL, LLC
HFS-HOU
In Commercial Distribution

  • 00814384020413 ()
411984-001

  • Pain management medication delivery system

Hands Free Syringe - 00814384020406

1 Foot pedal unit that controls injection/aspiration of HFS Sterile Syringe.
CONCERT MEDICAL, LLC
HFS-PDL
In Commercial Distribution

  • 00814384020406 ()
411983-001

  • Pain management medication delivery system

Hands Free Syringe - 00814384020383

Pouch of 1 sterile 20 mL syringe, stored inside a box of 20
CONCERT MEDICAL, LLC
HFS-SYR
In Commercial Distribution

  • 00814384020383 ()
  • 00814384020390 ()
411987-001

  • Pain management medication delivery system

Argyle - 10884527007103

CPAP Nasal Cannula with Bonnet,Babies 1000 g >1500 g
Cardinal Health, Inc.
8888163030
In Commercial Distribution

  • 20884527007100 ()
  • 10884527007103 ()

  • Clothing Size,Small,N/A;
8888163030

  • Nasal oxygen cannula, CPAP

Detecto - 00809161142709

Diaper/Lap Sponge Scale, Digital, 4000 g x 1 g
CARDINAL SCALE MANUFACTURING COMPANY
AP-4KD
In Commercial Distribution

  • 00809161142709 ()


  • Medical/surgical procedure scale, electronic

G7® Acetabular System - 05019279998227

No Description
Biomet Uk Ltd
110026856
In Commercial Distribution

  • 05019279998227 ()

  • Size G
110026856

  • Orthopaedic inorganic implant inserter/extractor, reusable

ACE Surgical Supply - 00614950008858

ACE 1 GRAM CALCIUM SULFATE HEMIHYDRATE KIT
ACE SURGICAL SUPPLY CO., INC.
5052001
In Commercial Distribution

  • 00614950008858 ()

  • 1 G
5052001

  • Dental root surface conditioner

ACE Surgical Supply - 00614950008865

ACE 0.5 GRAM CALCIUM SULFATE HEMIHYDRATE KIT
ACE SURGICAL SUPPLY CO., INC.
5052002
In Commercial Distribution

  • 00614950008865 ()

  • .5 G
5052002

  • Dental root surface conditioner

REGENX PuraCAL - 00614950008698

PuraCAL 1.0g Kit Medical Grade Calcium Sulfate
ACE SURGICAL SUPPLY CO., INC.
PGCS10
In Commercial Distribution

  • 00614950008698 ()

  • 1 G
PGCS10

  • Dental root surface conditioner

REGENX PuraCAL - 00614950008681

PuraCAL .5g Kit Medical Grade Calcium Sulfate
ACE SURGICAL SUPPLY CO., INC.
PGCS05
In Commercial Distribution

  • 00614950008681 ()

  • .5 G
PGCS05

  • Dental root surface conditioner

Kallestad ANCA - 00847817016165

Kallestad ANCA Phosphate Buffered Saline, 8.6 g
BIO-RAD LABORATORIES, INC.
29412
In Commercial Distribution

  • 00847817016165 ()

  • 8.6 g
29412

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, reagent

ARCOS - 00880304497504

No Description
Biomet Orthopedics, LLC
31-301367
In Commercial Distribution

  • 00880304497504 ()

  • SIZE G
31-301367

  • Bone-resection orthopaedic reamer, reusable

G7 PROVISIONAL NEUTRAL LINER - 00880304551800

No Description
Biomet Orthopedics, LLC
010002638
In Commercial Distribution

  • 00880304551800 ()

  • 40MM G
010002638

  • Acetabulum prosthesis trial, prefabricated, reusable

G7 PROVISIONAL HIGH WALL LINER - 00880304551640

No Description
Biomet Orthopedics, LLC
010002672
In Commercial Distribution

  • 00880304551640 ()

  • 40MM G
010002672

  • Acetabulum prosthesis trial, prefabricated, reusable

SIRIUS - 00880304543737

No Description
Biomet Orthopedics, LLC
31-149107
In Commercial Distribution

  • 00880304543737 ()

  • SIZE G
31-149107

  • Orthopaedic broach
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