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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A 1-way 60 drops with 60" tube Adset connected to a 3cc transducer. The Safedraw is assembled with a 5cc restricted syringe stops at 2cc, with a 12" Pressure Tubing from the patient and a 48" Pressure tubing to the syringe. It also includes a separately packed 2x male protective caps and a Label Set.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
682142
In Commercial Distribution

  • 50886333621427 ()
  • 00886333621422 ()

  • 3cc transducer, 60 drops Adset and 5cc syringe stops at 2cc
682142

  • Invasive-pressure external transducer, single-use
No Description
R82 A/S
Crocodile, Size 2 AT
In Commercial Distribution

  • 05715393021956 ()
86802AT

  • Handgrip disability-assistive walker, non-powered, foldable
No Description
R82 A/S
Crocodile, Size 1 AT
In Commercial Distribution

  • 05715393021949 ()
86801AT

  • Handgrip disability-assistive walker, non-powered, foldable
No Description
R82 A/S
Crocodile, Size 3 AT
In Commercial Distribution

  • 05715393022014 ()
86803AT-ATS

  • Handgrip disability-assistive walker, non-powered, foldable
No Description
R82 A/S
Crocodile, Size 2 AT
In Commercial Distribution

  • 05715393021987 ()
86802AT-ATS

  • Handgrip disability-assistive walker, non-powered, foldable
No Description
R82 A/S
Crocodile, Size 1 AT
In Commercial Distribution

  • 05715393021970 ()
86801AT-ATS

  • Handgrip disability-assistive walker, non-powered, foldable
No Description
R82 A/S
Crocodile, Size 3 AT
In Commercial Distribution

  • 05715393021963 ()
86803AT

  • Handgrip disability-assistive walker, non-powered, foldable
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
The Proteus XR/f AT Radiographic Systems with (or without) Digital Detector are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
Proteus XR/f AT
In Commercial Distribution

  • 08436046002319 ()


  • Stationary basic diagnostic x-ray system, digital
This Analog or Digital Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
RAD SYSTEM NOVA AT
In Commercial Distribution

  • 08436046002135 ()


  • Stationary basic diagnostic x-ray system, digital
  • Stationary basic diagnostic x-ray system, analogue
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
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
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
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
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
Parsonnet Aorta Clamp, 10-1/4" (26.0 cm), jaw length at base 1-3/4" (4.5 cm)
NOVO SURGICAL, INC.
C6672-58
In Commercial Distribution

  • 00842331125218 ()

  • Length: 4.5 Centimeter


  • Surgical A/V-shaped microvessel clamp
Parsonnet Aorta Clamp, 10-1/4" (26.0 cm), jaw length at base 1-1/2" (3.8 cm)
NOVO SURGICAL, INC.
C6672-57
In Commercial Distribution

  • 00842331125201 ()

  • Length: 3.8 Centimeter


  • Surgical A/V-shaped microvessel clamp
Parsonnet Aorta Clamp, 10-1/4" (26.0 cm), jaw length at base 1-1/4" (3.2 cm)
NOVO SURGICAL, INC.
C6672-56
In Commercial Distribution

  • 00842331125195 ()

  • Length: 3.2 Centimeter


  • Surgical A/V-shaped microvessel clamp
Parsonnet Aorta Clamp, 10-1/4" (26.0 cm), jaw length at base 1-1/8" (2.8 cm)
NOVO SURGICAL, INC.
C6672-55
In Commercial Distribution

  • 00842331125188 ()

  • Length: 2.8 Centimeter


  • Surgical A/V-shaped microvessel clamp
Parsonnet Aorta Clamp, 10-1/4" (26.0 cm), jaw length at base 1-3/4" (4.5 cm)
NOVO SURGICAL, INC.
5561-47
Not in Commercial Distribution

  • 00842331117732 ()

  • Length: 26 Centimeter
5561-47

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Parsonnet Aorta Clamp, 10-1/4" (26.0 cm), jaw length at base 1-1/4" (3.2 cm)
NOVO SURGICAL, INC.
5561-45
Not in Commercial Distribution

  • 00842331117718 ()

  • Length: 26 Centimeter
5561-45

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
blumenthal rongeur, 4.0 mm wide jaws, 6 1/4" (16.0 cm), beak at 45-degree angle
NOVO SURGICAL, INC.
N4136-56
In Commercial Distribution

  • 00842331147562 ()
N4136-56

  • Craniofacial rongeur, reusable
Parsonnet Aorta Clamp, 10-1/4" (26.0 cm), jaw length at base 1-1/2" (3.8 cm)
NOVO SURGICAL, INC.
5561-46
Not in Commercial Distribution

  • 00842331117725 ()

  • Length: 26 Centimeter
5561-46

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Parsonnet Aorta Clamp, 10-1/4" (26.0 cm), jaw length at base 1-1/8" (2.8 cm)
NOVO SURGICAL, INC.
5561-44
Not in Commercial Distribution

  • 00842331117701 ()

  • Length: 26 Centimeter
5561-44

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
young renal pedicle clamp, curved, longitudinal serrations w/ cross serrations at tip, 9" (22.9 cm)
NOVO SURGICAL, INC.
G6268-94
In Commercial Distribution

  • 00842331131240 ()
G6268-94

  • Open-surgery biopsy forceps, reusable
novo meniscus clamp, curved shank, 1x2 teeth at jaw tip, 7 1/4" (18.4 cm)
NOVO SURGICAL, INC.
N4632-32
In Commercial Distribution

  • 00842331142307 ()
N4632-32

  • Open-surgery biopsy forceps, reusable
blumenthal rongeur, 4.0 mm wide jaws, 6 1/4" (16.0 cm), beak at 30-degree angle
NOVO SURGICAL, INC.
N4136-41
In Commercial Distribution

  • 00842331138881 ()
N4136-41

  • Craniofacial rongeur, reusable
rosen cartilage knife, double-ended, blades at 45 degrees & 90 degrees, 7 5/8" (19.5 cm)
NOVO SURGICAL, INC.
E7821-91
In Commercial Distribution

  • 00842331182686 ()
E7821-91

  • Skin grafting knife
blumenthal rongeur, 4.0 mm wide jaws, 6 1/4" (16.0 cm), beak at 90-degree angle
NOVO SURGICAL, INC.
N4136-01
In Commercial Distribution

  • 00842331178429 ()
N4136-01

  • Craniofacial rongeur, 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
Toric IOL Reference Marker, Conical Micro-Teeth Positioned at 0, 90, and 180 Degrees, Stainless Steel
Diamatrix
M24400
In Commercial Distribution

  • 00813059013880 ()


  • Corneal marker, reusable
Re-usable fiberoptic handpiece for lasers. 190mm/163.1 with 35 degree bend. 30.7R at tip. Blue.
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
1059712
In Commercial Distribution

  • B17710597120 ()


  • General/multiple surgical laser system beam guide, reusable
Cloward Blade Retractor w/ slight lip 21mm, w/ graduation markings at 35mm, 45mm, 55mm, 65mm
Avalign Technologies, Inc.
63-G1048SPG
In Commercial Distribution

  • 00190776377779 ()


  • Hand-held surgical retractor, 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® 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® 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
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® 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
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
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
Integra® Saunders Paparella Window Rasp & Marker, Malleable Shaft Marked at 4, 4.5, & 5 mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3722107
In Commercial Distribution

  • 10381780082194 ()
3722107

  • Middle ear file/rasp
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
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
MENISCUS CLAMP WITH CURVED SHANK, 1 X 2 TEETH AT TIP OF JAWS, STAINLESS STEEL
ELMED INCORPORATED
23-5274OS
In Commercial Distribution

  • 00198506057007 ()
23-5274OS

  • Arthroscopic surgical procedure kit, non-medicated, reusable
ri-champion® N is a non-invasive blood pressure monitors for measuring at the upper arm
Rudolf Riester GmbH
1725-145
In Commercial Distribution

  • 04045396155374 ()
1725-145

  • Automatic-inflation electronic sphygmomanometer, non-portable
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