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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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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 - 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 - 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 - 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

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

Critica Cover - 10817583023015

Sleeve Protector, NuTech, White, Sonic Welded, Elastic at both ends, UNIV
Alpha Pro Tech, Inc.
MS-01606-8
In Commercial Distribution

  • 20817583023012 ()
  • 10817583023015 ()
  • 00817583023018 ()
MS-01606-8

  • Surgical sleeve cover

Critical Cover - 10817583023008

Sleeve Protector, NuTech, White, Sonic Welded, Elastic at both ends, XL
Alpha Pro Tech, Inc.
MS-01606-4
In Commercial Distribution

  • 20817583023005 ()
  • 10817583023008 ()
  • 00817583023001 ()
MS-01606-4

  • Surgical sleeve cover

Critical Cover - 10817583022995

Sleeve Protector, GenPro, White, Serged Seams, Elastic at both ends, UNIV
Alpha Pro Tech, Inc.
MS-01135-8
In Commercial Distribution

  • 20817583022992 ()
  • 10817583022995 ()
  • 00817583022998 ()
MS-01135-8

  • Surgical sleeve cover

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

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

Aero-Med - 10885380176166

Blood Culture Collection Kit, Robert Wood Johnson at New Brunswick Only
AERO-MED, LLC
CA10875
In Commercial Distribution

  • 50885380176164 ()
  • 10885380176166 ()
CA10875

  • Phlebotomy kit

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

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

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

Medetz Surgical Instruments - G223928400

Toric IOL Reference Marker Blades are positioned at 0, 90, 180 Degrees, Head is angled at 70 degrees, Round Knurled Handle, 98mm Overall Length, Stainless Steel
Medetz Surgical Instruments LLC
92-840
In Commercial Distribution

  • G223928400 ()


  • Corneal marker, reusable

MR PHACO - G412PH95170

Toric IOL Reference Marker Blades are positioned at 0, 90, 180 Degrees, Head is angled at 70 degrees, Round Knurled Handle, 98mm Overall Length, Stainless Steel
Crestpoint Management Limited
PH9517
In Commercial Distribution

  • G412PH95170 ()


  • Corneal marker, reusable

ANTHEM - 00889095960433

ANTHEM MIDSHAFT42 Superior Clavicle Plate, Right, Deep Curve, 12 Holes, 121mm, SS
GLOBUS MEDICAL, INC.
2186.2432
In Commercial Distribution

  • 00889095960433 ()

  • Centered at 42%
  • Length: 121 Millimeter
  • Deep Right Contour
  • 12 Shaft Holes


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

ANTHEM - 00889095960402

ANTHEM MIDSHAFT42 Superior Clavicle Plate, Right, Deep Curve, 9 Holes, 91mm, SS
GLOBUS MEDICAL, INC.
2186.2429
In Commercial Distribution

  • 00889095960402 ()

  • 9 Shaft Holes
  • Deep Right Contour
  • Length: 91 Millimeter
  • Centered at 42%


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

ANTHEM - 00889095960389

ANTHEM MIDSHAFT42 Superior Clavicle Plate, Right, Deep Curve, 7 Holes, 72mm, SS
GLOBUS MEDICAL, INC.
2186.2427
In Commercial Distribution

  • 00889095960389 ()

  • Centered at 42%
  • 7 Shaft Holes
  • Deep Right Contour
  • Length: 72 Millimeter


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

ANTHEM - 00889095960365

ANTHEM MIDSHAFT42 Superior Clavicle Plate, Right, Shallow Curve, 12 Holes, 125mm, SS
GLOBUS MEDICAL, INC.
2186.2412
In Commercial Distribution

  • 00889095960365 ()

  • Length: 125 Millimeter
  • Shallow Right Contour
  • 12 Shaft Holes
  • Centered at 42%


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

ANTHEM - 00889095960334

ANTHEM MIDSHAFT42 Superior Clavicle Plate, Right, Shallow Curve, 9 Holes, 95mm, SS
GLOBUS MEDICAL, INC.
2186.2409
In Commercial Distribution

  • 00889095960334 ()

  • Centered at 42%
  • Length: 95 Millimeter
  • Shallow Right Contour
  • 9 Shaft Holes


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

ANTHEM - 00889095960310

ANTHEM MIDSHAFT42 Superior Clavicle Plate, Right, Shallow Curve, 7 Holes, 75mm, SS
GLOBUS MEDICAL, INC.
2186.2407
In Commercial Distribution

  • 00889095960310 ()

  • Centered at 42%
  • Length: 75 Millimeter
  • 7 Shaft Holes
  • Shallow Right Contour


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

ANTHEM - 00889095959857

ANTHEM MIDSHAFT42 Superior Clavicle Plate, Left, Deep Curve, 12 Holes, 121mm, SS
GLOBUS MEDICAL, INC.
2186.1432
In Commercial Distribution

  • 00889095959857 ()

  • Centered at 42%
  • 12 Shaft Holes
  • Deep Left Contour
  • Length: 121 Millimeter


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

ANTHEM - 00889095959826

ANTHEM MIDSHAFT42 Superior Clavicle Plate, Left, Deep Curve, 9 Holes, 91mm, SS
GLOBUS MEDICAL, INC.
2186.1429
In Commercial Distribution

  • 00889095959826 ()

  • Centered at 42%
  • Length: 91 Millimeter
  • 9 Shaft Holes
  • Deep Left Contour


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

ANTHEM - 00889095959802

ANTHEM MIDSHAFT42 Superior Clavicle Plate, Left, Deep Curve, 7 Holes, 72mm, SS
GLOBUS MEDICAL, INC.
2186.1427
In Commercial Distribution

  • 00889095959802 ()

  • Length: 72 Millimeter
  • 7 Shaft Holes
  • Deep Left Contour
  • Centered at 42%


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
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