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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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CVS Health At Home COVID-19 Test Kit - 30014613340188

QuickVue COVID-19 Test
DIAGNOSTIC HYBRIDS, INC.
20452
In Commercial Distribution

  • 30014613340188 ()
289586

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

Integra® Ruggles®-Redmond™ - 10381780194446

John Day Periosteal Elevator, 8", Angled 30° At Cup, 6mm Cup
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
R8907
Not in Commercial Distribution

  • M274R89071 ()
  • 10381780194446 ()
R8907

  • Neurosurgical bone flap elevator

MasterPeace - 07350121950566

Table Shield. To be placed at the foot end of table
Texray AB
Table Shield End
In Commercial Distribution

  • 07350121950566 ()

  • Width: 90 Centimeter
  • Length: 80 Centimeter
TS3050

  • Radiation shielding table drape

Accu-Beam - B1770966060

Re-usable fiberoptic handpiece for lasers. 400mm, double bend at handle & tip.
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
096606
In Commercial Distribution

  • B1770966060 ()


  • General/multiple surgical laser system beam guide, reusable

BOSS Instruments - 00888515027725

Seletz Gelpi Ret, arms bent at rt ang, 6 3/4"
BOSS INSTRUMENTS, LTD., INC.
18-3100
In Commercial Distribution

  • 00888515027725 ()
18-3100

  • Self-retaining surgical retractor, reusable

TRUE METRIX AIR - 00311917173894

Well at Walgreens TRUE METRIX AIR self monitoring blood glucose meter
TRIVIDIA HEALTH, INC.
TRUE METRIX AIR self monitoring blood glucose meter
In Commercial Distribution

  • 10311917173891 ()
  • 00311917173894 ()
  • 00021292007720 ()
REA4001-01

  • Glucose monitoring system IVD, home-use

Aero-Med - 10885380181207

Swab Saline At Home Collection and Transport Kit, Cleveland Clinic Only
AERO-MED, LLC
CA33575
In Commercial Distribution

  • 50885380181205 ()
  • 10885380181207 ()
CA33575

  • Specimen mailer kit

Millennium - 00190776394677

Cobra Retractor, medium, 46mm blade at widest, 7" handle, 12" OL
Avalign Technologies, Inc.
1-6132
In Commercial Distribution

  • 00190776394677 ()


  • Hand-held surgical retractor, reusable

Millennium - 00190776374518

Oral Surgery Rongeur, #4A, 6 1/2", jaws at 35deg angle
Avalign Technologies, Inc.
1-22488
In Commercial Distribution

  • 00190776374518 ()


  • Dental rongeur

Lac-Mac - 00627755250636

Large Mayo Stand Cover ,62X27,Level 4,Yellow Bias at top
Lac-Mac Limited
075XX
In Commercial Distribution

  • 00627755250636 ()

  • Height: 27 Inch
  • Width: 62 Inch
075XX

  • Patient surgical drape, reusable

EXIN - 04719871894002

30 M Corrugated Tube (22 mm,cuffed at 0.15 cm,transparent)
FOREMOUNT ENTERPRISE CO., LTD.
152102
In Commercial Distribution

  • 04719871894002 ()


  • Straight/elbow breathing circuit connector, single-use

MSI Precision Specialty Instruments - 00194613119300

Hu Capsule Polisher Ring Tip Set at 90 Degrees, Round Handle
Med Saver, Inc.
5-1756
In Commercial Distribution

  • 00194613119300 ()


  • Ophthalmic surgical probe, reusable

A. Titan Instruments - 00841685101091

Osteotome, angled, convex, 4.0 mm < 4.5 mm, Depth marks at: 8-10-13-15-16mm
A. TITAN INSTRUMENTS, INC.
321.05
In Commercial Distribution

  • 00841685101091 ()


  • Dental osteotome

A. Titan Instruments - 00841685101046

Osteotome, straight, convex, 4.5 mm < 5.0 mm, Depth marks at: 8-10-13-15-16mm
A. TITAN INSTRUMENTS, INC.
320.06
In Commercial Distribution

  • 00841685101046 ()


  • Dental osteotome

A. Titan Instruments - 00841685101022

Osteotome, straight, convex, 3.5 mm < 4.0 mm, Depth marks at: 8-10-12-15-16mm
A. TITAN INSTRUMENTS, INC.
320.04
In Commercial Distribution

  • 00841685101022 ()


  • Dental osteotome

N/A - 00857863007871

Corrugated Tubing, Blue, Scored at 6 inch, 22 mm, 100 FT
Medi/Nuclear Corporation, Inc.
MN9680
In Commercial Distribution

  • 00857863007871 ()


  • Aerosol delivery tubing

3C Patch® Device - 05714188502151

Holds the blood at collection and during processing in the centrifuge.
Reapplix ApS
1
Not in Commercial Distribution

  • 05714188502151 ()


  • Haematological concentrate system preparation kit, platelet concentration

3C Patch® Device - 05714188502106

Holds the blood at collection and during processing in the centrifuge.
Reapplix ApS
2
In Commercial Distribution

  • 05714188502106 ()


  • Haematological concentrate system preparation kit, platelet concentration

Hayden Medical - 00840319708286

Kleegman Dilator 10-3/4" (26.9cm), 1-3mm at tips, double ended TEFLON
Hayden Medical, Inc.
290-003T
In Commercial Distribution

  • 00840319708286 ()
290-003T

  • Fixed-diameter cervical dilator, reusable

Hayden Medical - 00840319721698

McKenty Septum Elevator 5-1/2" (13.8cm), curved at tip, 5mm wide
Hayden Medical, Inc.
210-063
In Commercial Distribution

  • 00840319721698 ()
210-063

  • ENT elevator

Hayden Medical - 00840319721681

McKenty Septum Elevator 5-1/2" (13.8cm), curved at tip, 4mm wide
Hayden Medical, Inc.
210-062
In Commercial Distribution

  • 00840319721681 ()
210-062

  • ENT elevator

Hayden Medical - 00840319739730

Potts-Smith Dressing Forceps 12" (30cm), serrated, NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-159NC
In Commercial Distribution

  • 00840319739730 ()
120-159NC

  • Dressing/utility forceps, tweezers-like, reusable

Hayden Medical - 00840319739358

Tissue Forceps 8" (20cm), 1x2 teeth, NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-048NC
In Commercial Distribution

  • 00840319739358 ()
120-048NC

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable

Hayden Medical - 00840319703519

Potts-Smith Dressing Forceps 7" (17.5cm), serrated, NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-154NC
In Commercial Distribution

  • 00840319703519 ()
120-154NC

  • Dressing/utility forceps, tweezers-like, reusable

Life Instruments - M930712013013900

American Rainbow Curette#3/0 Ang 90deg at 2mm from Cup
Life Instrument Corporation
712-0130-1-3-90
In Commercial Distribution

  • M930712013013900 ()


  • Bone curette, reusable

HELMUT ZEPF - EZPF50229160

PLIERS, OPERATIVE DEBAKEY AT FCPS/PLIERS OPERATIVE,MODIF. 16 CM, ANGELED
Helmut Zepf Medizintechnik GmbH
50.229.16
In Commercial Distribution

  • EZPF50229160 ()
50.229.16

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable

Duality - 08059173396368

Dermatological and aesthetic laser device operating at 1064 and 532 nm.
QUANTA SYSTEM SPA
PCMS00354
In Commercial Distribution

  • 08059173396368 ()


  • Dermatological frequency-doubled solid-state laser system

Critical Cover - 10817583023053

Sleeve Protector, ComforTech, White, Sonic Welded, Elastic at both ends, UNIV
Alpha Pro Tech, Inc.
MS-01J06-8TH
In Commercial Distribution

  • 20817583023050 ()
  • 10817583023053 ()
  • 00817583023056 ()
MS-01J06-8TH

  • Surgical sleeve cover

Critical Cover - 10817583023046

Sleeve Protector, ComforTech, White, Sonic Welded, Elastic at both ends, UNIV
Alpha Pro Tech, Inc.
MS-01J06-8
In Commercial Distribution

  • 20817583023043 ()
  • 10817583023046 ()
  • 00817583023049 ()
MS-01J06-8

  • Surgical sleeve cover

Critical Cover - 10817583023039

Sleeve Protector, ComforTech, White, Sonic Welded, Elastic at both ends, XL
Alpha Pro Tech, Inc.
MS-01J06-4
In Commercial Distribution

  • 20817583023036 ()
  • 10817583023039 ()
  • 00817583023032 ()
MS-01J06-4

  • Surgical sleeve cover
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