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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PureSkin Latex Powder-Free, X-Small, Fully-textured, Polymer-coated, Packaging contains at least 70% recycled material
PURELIFE, LLC
1020101
In Commercial Distribution

  • D79010201010 ()
  • D79010201011 ()
1020101

  • Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Integra® Jarit® Mini-Blumenthal Oral Rongeur, 5-1/4", Jaws at 25° Angle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
837110
In Commercial Distribution

  • M2748371101 ()
  • 10381780207443 ()
837-110

  • Dental rongeur
Re-usable fiberoptic handpiece for lasers. 75.1mm bend, Rigid with 30.7mm bend at tip
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
9190
In Commercial Distribution

  • B17791900 ()


  • General/multiple surgical laser system beam guide, reusable
Cushing Bayonet Dressing Forceps 7-1/4" (18.4cm), serrated, non-conductive, exposed at both ends
Hayden Medical, Inc.
120-190NC
In Commercial Distribution

  • 00840319703656 ()
120-190NC

  • Dressing/utility forceps, tweezers-like, reusable
Sterile transparent PVC suction tube with 2 connectors at the extremities. Length: 2.70m
HYGITECH
HY-12025
In Commercial Distribution

  • 03615140001915 ()
  • 03615140001908 ()
  • 03615140001922 ()
HY-12025

  • Airway suction catheter
Reusable Bipolar Forceps with 0.7mm Tips Angled 45 Degrees Up at 1cm (Special)
KIRWAN SURGICAL PRODUCTS LLC
10-2402AUS
In Commercial Distribution

  • 00841019122297 ()


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Cottle Chisel, 7 1/4", 4mm, depth markings at 20, 30, 40, & 50mm
Avalign Technologies, Inc.
1-410290
In Commercial Distribution

  • 00190776382223 ()


  • Plastic surgery osteotome
RBP-100 is a non-invasive blood pressure monitors for measuring at the upper arm
Rudolf Riester GmbH
1742
In Commercial Distribution

  • 04045396214590 ()
1742

  • Automatic-inflation electronic sphygmomanometer, non-portable
RBP-100 is a non-invasive blood pressure monitors for measuring at the upper arm
Rudolf Riester GmbH
1743
In Commercial Distribution

  • 04045396208971 ()
1743

  • Automatic-inflation electronic sphygmomanometer, non-portable
RBP-100 is a non-invasive blood pressure monitors for measuring at the upper arm
Rudolf Riester GmbH
1741
In Commercial Distribution

  • 04045396208858 ()
1741

  • Automatic-inflation electronic sphygmomanometer, non-portable
RBP-100 is a non-invasive blood pressure monitors for measuring at the upper arm
Rudolf Riester GmbH
1740
In Commercial Distribution

  • 04045396208797 ()
1740

  • Automatic-inflation electronic sphygmomanometer, non-portable
Vaginal Packing x ray detectable loop stitched at one end 2" x 72"
Dermapac Inc.
5551
In Commercial Distribution

  • 00810102270481 ()
  • 10810102270488 ()


  • Radiopaque woven surgical sponge
Reverdin Suture Passing Needle 8-1/4" (21cm), curved with 2mm hole at tip
Hayden Medical, Inc.
405-698
In Commercial Distribution

  • 00840319751114 ()
405-698

  • Suture kit, medicated
Reverdin Suture Passing Needle 6" (15cm), slightly curved with 2mm hole at tip
Hayden Medical, Inc.
405-695
In Commercial Distribution

  • 00840319751084 ()
405-695

  • Suture kit, medicated
Adson Dura & Dissecting Hook 8" (20cm), sharp blade 5mm at a right angle
Hayden Medical, Inc.
210-168
In Commercial Distribution

  • 00840319744550 ()
210-168

  • Soft-tissue surgical hook, reusable
Gerald Tissue Forceps 7" (17.5cm), straight, 1x2 teeth, NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-182NC
In Commercial Distribution

  • 00840319703618 ()
120-182NC

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
Potts-Smith Tissue Forceps 9-1/2" (23.8cm), 1x2 teeth, NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-164NC
In Commercial Distribution

  • 00840319703557 ()
120-164NC

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
Potts-Smith Tissue Forceps 8-1/4" (20.6cm), 1x2 teeth, NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-162NC
In Commercial Distribution

  • 00840319739754 ()
120-162NC

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
Determination of the functional activity of antithrombin III (AT III) in human plasma
Siemens Healthcare Diagnostics Products GmbH
10446673
In Commercial Distribution

  • 00842768013478 ()
OWWR17

  • Antithrombin III (ATIII) IVD, kit, chromogenic
Determination of the functional activity of antithrombin III (AT III) in human plasma
Siemens Healthcare Diagnostics Products GmbH
10446672
In Commercial Distribution

  • 00842768013461 ()
OWWR15

  • Antithrombin III (ATIII) IVD, kit, chromogenic
kelman dipstick, 19-gauge cannula, marked at 5.0, 6.0, & 7.0 mm, 2 irrigating ports
NOVO SURGICAL, INC.
OP7120-38
In Commercial Distribution

  • G586OP7120380 ()
OP7120-38

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
KNEE FUSION FEMORAL ANTEGRADE NAIL 11.5-10MM X 78CM WITH STEP AT 57CM RIGHT
Smith & Nephew, Inc.
XT001132-1
In Commercial Distribution

  • 00885556742211 ()
XT001132-1

  • Femur intramedullary nail
Welch Allyn Miller #4 Standard Laryngoscope Blade; Lamp at Distal Tip; Stainless Steel
WELCH ALLYN, INC.
901038
In Commercial Distribution

  • 00732094141726 ()
68044

  • Rigid intubation laryngoscope, reusable
Welch Allyn Miller #00 Standard Laryngoscope Blade; Lamp at Distal Tip; Stainless Steel
WELCH ALLYN, INC.
901038
In Commercial Distribution

  • 00732094141702 ()
68045

  • Rigid intubation laryngoscope, reusable
KNEE FUSION FEMORAL ANTEGRADE NAIL 11.5MM X 77CM WITH STEP AT 52CM LEFT
Smith & Nephew, Inc.
XT001157-1
In Commercial Distribution

  • 00885556808047 ()
XT001157-1

  • Femur intramedullary nail
Welch Allyn Miller #0 Standard Laryngoscope Blade; Lamp at Distal Tip; Stainless Steel
WELCH ALLYN, INC.
901038
In Commercial Distribution

  • 00732094141795 ()
68040

  • Rigid intubation laryngoscope, reusable
Welch Allyn Miller #1 Standard Laryngoscope Blade; Lamp at Distal Tip; Stainless Steel
WELCH ALLYN, INC.
901038
In Commercial Distribution

  • 00732094141788 ()
68041

  • Rigid intubation laryngoscope, reusable
Welch Allyn Miller #2 Standard Laryngoscope Blade; Lamp at Distal Tip; Stainless Steel
WELCH ALLYN, INC.
901038
In Commercial Distribution

  • 00732094141764 ()
68042

  • Rigid intubation laryngoscope, reusable
Welch Allyn Miller #3 Standard Laryngoscope Blade; Lamp at Distal Tip; Stainless Steel
WELCH ALLYN, INC.
901038
In Commercial Distribution

  • 00732094141740 ()
68043

  • Rigid intubation laryngoscope, reusable
The Human Assayed Multi-sera is supplied at 2 levels, level 2 and 3. Target values and ranges are supplied for the analytes listed in the values section at both levels.
RANDOX LABORATORIES LIMITED
HE1532
In Commercial Distribution

  • 05055273203608 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
The Human Assayed Multi-sera is supplied at 2 levels, level 2 and 3. Target values and ranges are supplied for the analytes listed in the values section at both levels.
RANDOX LABORATORIES LIMITED
HS2611
In Commercial Distribution

  • 05055273203813 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
The Human Assayed Multi-sera is supplied at 2 levels, level 2 and 3. Target values and ranges are supplied for the analytes listed in the values section at both levels.
RANDOX LABORATORIES LIMITED
HN1530
In Commercial Distribution

  • 05055273203783 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
It's designed for family and individual users to track heart activity at home, at work or on a trip in case of cardiac situation that needs evaluation on the spot.
EMAY (HK) LIMITED
EMG-6L
In Commercial Distribution

  • 04897087206120 ()


  • Telemetric electrocardiographic ambulatory recorder
It's designed for family and individual users to track heart activity at home, at work or on a trip in case of cardiac situation that needs evaluation on the spot.
EMAY (HK) LIMITED
EMG-20
In Commercial Distribution

  • 04897087200203 ()


  • Electrocardiographic monitor
It's designed for family and individual users to track heart activity at home, at work or on a trip in case of cardiac situation that needs evaluation on the spot.
EMAY (HK) LIMITED
EMG-10
Not in Commercial Distribution

  • 04897087200104 ()


  • Electrocardiographic monitor
ProMax Surgical Gown, MLR Front Yoke, Comfort Panel Back with Negastat, Snap Closures at Neck, Tape Tie Closures at Waist, With QCM, Circumferentially Offset Sleeves, Double-needle Flat Felled Chainstitch Construction
STANDARD TEXTILE CO., INC.
75614905
In Commercial Distribution

  • 00634916795493 ()


  • Surgical gown, reusable
Miyoshi Ultimate Vertical Dual Flow Hydrodissectional Cannula 25ga, Angled 45 Degrees at 1.5mm bend to tip, .2mm Dual Ports set at 120 Degrees, Smooth closed sandblasted tip, 22mm Overall Length
Crestpoint Management Limited
CA1628
In Commercial Distribution

  • G412CA16280 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Miyoshi Ultimate Vertical Dual Flow Hydrodissectional Cannula 23ga, Angled 45 Degrees at 1.5mm bend to tip, .2mm Dual Ports set at 120 Degrees, Smooth closed sandblasted tip, 22mm Overall Length
Crestpoint Management Limited
CA1627
In Commercial Distribution

  • G412CA16270 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
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
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