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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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No Description
MORIA SA
DSAEK Spatula at 90°
In Commercial Distribution

  • 03700483606559 ()
19083/B

  • General-purpose surgical spatula
No Description
MORIA SA
DSAEK Spatula at 45°
In Commercial Distribution

  • 03700483606542 ()
19083/A

  • General-purpose surgical spatula
No Description
MORIA SA
DSAEK Spatula at 90°
In Commercial Distribution

  • 03700483606535 ()
19077/B

  • General-purpose surgical spatula
No Description
MORIA SA
DSAEK Spatula at 45°
In Commercial Distribution

  • 03700483606528 ()
19077/A

  • General-purpose surgical spatula
Terragene® Bionova© Reader Incubators (Mini-Bio) incubate at 60 °C and 37 °C and read the Terragene® Bionova© SCBI for fluorescent results at the times prescribed in the User Manuals.
Plasmapp Co.,Ltd.
Mini-bio
In Commercial Distribution

  • 08800066500221 ()


  • Biological sterilization indicator reader
2-Ply Front/Sleeves Aqua Compel MLR and White ComPel MLR with Negastat, 1-Ply Aqua MLR Comfort Panel Backs, Snap Closures at Neck, Tie Closures at Waist, Circumferentially Offset Sleeves, Overcast Safety Stitch Body
STANDARD TEXTILE CO., INC.
75647454
In Commercial Distribution

  • 00634916788358 ()


  • Surgical gown, reusable
VERIFY Dual Temperature 28 well incubator allows incubation at two different temperatures in one incubator
STERIS CORPORATION
Incubator
In Commercial Distribution

  • 00724995023911 ()
S3080

  • Test tube heater
Proov PdG, Progesterone Metabolite Test. The only FDA-Cleared Test to Confirm Successful Ovulation at Home.
Mfb Fertility, Inc.
Confirm
In Commercial Distribution

  • 00860002790817 ()


  • Natural conception assistance kit
microTargeting Single Insertion Tube with Stylet, Sterile, at target, for use with Nexframe and Nexdrive
FHC, INC.
66-IT-DB12P-00327
In Commercial Distribution

  • 10873263003272 ()
  • 00873263003275 ()

  • Length: 211.6 Millimeter
  • Lumen/Inner Diameter: 1.6 Millimeter
  • Outer Diameter: 1.83 Millimeter
66-IT-DB12P

  • Intracerebral cannula, implantable
At home fertility test that measures all 4 cycle hormones for a comprehensive fertility map.
Mfb Fertility, Inc.
Pregnancy Pack
In Commercial Distribution

  • 00850035206126 ()


  • Natural conception assistance kit
Twist Drill Triangle Shape to start osteotomy, with laser marks at 6-8-10-12-14-16mm. Made of Steel.
CERAROOT SL.
001.001
In Commercial Distribution

  • 08435453900256 ()

  • Outer Diameter: 2 Millimeter
001.001

  • Fixture/appliance dental drill bit, reusable
Nordan colibri forceps, 4 1/8'', 0.12mm 1x2 teeth set at 45 degrees, round handle
AMBLER SURGICAL CORP.
Nordan colibri forceps
In Commercial Distribution

  • 00190660204914 ()
2371E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Ambler colibri forceps, 3'', very delicate, 0.12mm 1x2 teeth set at 90 degrees, flat handle
AMBLER SURGICAL CORP.
Ambler colibri forceps
In Commercial Distribution

  • 00190660039158 ()
9507E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Ambler colibri forceps, 3'', 0.4mm 1x2 teeth set at 90 degrees, with 6.0mm tying platform
AMBLER SURGICAL CORP.
Ambler colibri forceps
In Commercial Distribution

  • 00190660039141 ()
9540E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
LITTAUER Suture Scissors, straight, 5 1/4", (135 mm), notch at the tip, non-sterile, reusable
Aesculap AG
BC803R
In Commercial Distribution

  • 04038653022328 ()
BC803R

  • General-purpose surgical scissors, reusable
SPENCER Suture Scissors, straight, 4 1/2", (115 mm), notch at the tip, non-sterile, reusable
Aesculap AG
BC802R
In Commercial Distribution

  • 04038653022311 ()
BC802R

  • General-purpose surgical scissors, reusable
SPENCER Suture Scissors, straight, 3 1/2", (90 mm), notch at the tip, non-sterile, reusable
Aesculap AG
BC801R
In Commercial Distribution

  • 04038653022304 ()
BC801R

  • General-purpose surgical scissors, reusable
Integra® Miltex® Friedman Oral Surgery Rongeur 5-5/8", Delicate, Jaws at 25° Angle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
22-494
In Commercial Distribution

  • H834224940 ()
  • 10381780424710 ()
22-494

  • Dental rongeur
Integra® Miltex® McPherson Suture Tying Forceps 3-1/2", Angled, 0.33mm wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-949
In Commercial Distribution

  • H834189490 ()
  • 10381780418429 ()

  • 3-1/2"
  • Width: 0.35 Millimeter
18-949

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Integra® Miltex® Eye Dressing Forceps, 4", Standard, Straight, Serrated, 0.8mm Wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-780
In Commercial Distribution

  • H834187800 ()
  • 10381780417835 ()

  • Width: 0.8 Millimeter
  • Length: 4 Inch
18-780

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
7 1/8 inch Meniscus Clamp, Curved Shanks, 1 X 2 Teeth At Jaw Tip
Surgical Direct, Inc.
SD914746102
In Commercial Distribution

  • B382SD9147461020 ()
SD914746102

  • Orthopaedic bone-fragment manipulator, reusable
Integra® Miltex® McPherson Suture Tying Forceps 3-1/2", Straight, 0.33mm wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-948
In Commercial Distribution

  • H834189480 ()
  • 10381780418412 ()

  • Width: 0.35 Millimeter
  • 3-1/2"
18-948

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
7 1/2" Double Ended Rosen Cartilage Knife, Blades Set At 45 and 90 Degree
Surgical Direct, Inc.
SD920661101
In Commercial Distribution

  • B382SD9206611010 ()
SD920661101

  • Ear excavator
Integra® Miltex® McPherson Suture Tying Forceps, 3-1/2", Angled, 0.3mm Wide At Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
MH18-949
In Commercial Distribution

  • H834MH189490 ()
  • 10381780487395 ()
MH18-949

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Skillern sinus probe, 6 1/2'', graduated beads at 5cm, 7cm and 9cm, probe tip
AMBLER SURGICAL CORP.
Skillern sinus probe
In Commercial Distribution

  • 00190660128074 ()
44-660

  • Fistula probe
SKILLERN Sinus Probe, 6 7/8" (175 mm), malleable, beads at 50mm, 70mm and 90mm
AESCULAP, INC.
MA408R
In Commercial Distribution

  • 04046964586958 ()
MA408R

  • Mastoid gauge
PLIERS, OPERATIVE DEBAKEY AT FCPS/PLIERS OPERATIVE,MODIF. STRAIGHT, 16 CM, MOUTH WIDTHNESS 1,7 MM
Helmut Zepf Medizintechnik GmbH
50.226.16
In Commercial Distribution

  • EZPF50226160 ()
50.226.16

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
Lead mittens - 15" one piece dip molded - w/ slit at base of fingers for dexterity
Shielding International Inc.
101SLMITRL
In Commercial Distribution

  • G031101SLMITRL0 ()


  • Radiation-shielding procedure preparation glove/mitten
Exchangeable suction-Irrigation tube M8 x 1, Ø 10mm, markings and 4 holes at distal end
Pajunk GmbH Medizintechnologie
1298-00-10
Not in Commercial Distribution

  • 04048223006610 ()
1298-00-10

  • Laparoscopic access cannula, reusable
Exchangeable suction-Irrigation tube M8 x 1, Ø 5mm, markings and 4 holes at distal end
Pajunk GmbH Medizintechnologie
1298-00-05
Not in Commercial Distribution

  • 04048223006597 ()
1298-00-05

  • Laparoscopic access cannula, reusable
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