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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Device for grasping tissue; to be used in combination with the symphonX Handle, Handle with ratchet, Handle with on/off ratchet.
Fortimedix Surgical B.V.
Grasper
Not in Commercial Distribution

  • 08719324463119 ()
  • 08719324463010 ()
314-001

  • Rigid endoscopic tissue manipulation forceps, single-use
Elvarex 2/Arm sleeve with bias top end and glove, one piece/With Finger, with Thumb/Dotted Silicone band inside/Honey
BSN-Jobst GmbH
77361-00171-00
In Commercial Distribution

  • 04019702535471 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Arm sleeve with bias top end and glove, one piece/With Finger, with Thumb/Dotted Silicone band inside/Cranberry
BSN-Jobst GmbH
77361-00147-00
In Commercial Distribution

  • 04019702534450 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex Forte 2/Arm sleeve with bias top end and glove, one piece/With Finger, with Thumb/Dotted Silicone band inside
BSN-Jobst GmbH
79583-00003-00
In Commercial Distribution

  • 04019702511451 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 1/Arm sleeve with bias top end and glove, one piece/With Finger, with Thumb/Dotted Silicone band inside/Honey
BSN-Jobst GmbH
77328-00165-00
In Commercial Distribution

  • 04019702539202 ()

  • Pressure: 15-21 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 1/Arm sleeve with bias top end and glove, one piece/With Finger, with Thumb/Dotted Silicone band inside/Cranberry
BSN-Jobst GmbH
77328-00141-00
In Commercial Distribution

  • 04019702539066 ()

  • Pressure: 15-21 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX 1/BODY BANDAGE WITH LEG EXTENSION/WITH SLIP FORM ON BOTH SIDES WITH ADJUSTABLE WAIST BAND/FLY FOR MEN/NAVY
BSN-Jobst GmbH
77323-00051-00
In Commercial Distribution

  • 04019702485127 ()

  • Pressure 18-21 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX 2/BODY BANDAGE WITH LEG EXTENSION/WITH SLIP FORM ON BOTH SIDES WITH ADJUSTABLE WAIST BAND/FLY FOR MEN/GRAPHITE
BSN-Jobst GmbH
77356-00235-00
In Commercial Distribution

  • 04019702861792 ()

  • Pressure 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
EVO Bag, 500-2000ml Fill Volume, with one male luer with cap, two female luers with caps, and a needle-free injection port
ORIGEN BIOMEDICAL, INC.
EV3000N
In Commercial Distribution

  • 20816203021865 ()
  • 10816203021868 ()
EV3000N

  • Blood/tissue storage/culture container
ELVAREX 2/BODY BANDAGE WITH LEG EXTENSION/WITH SLIP FORM ON BOTH SIDES WITH ADJUSTABLE WAIST BAND/FLY FOR MEN/COCOA
BSN-Jobst GmbH
77356-00076-00
In Commercial Distribution

  • 04019702423181 ()

  • Pressure 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Body Bandage with Leg Extension/with slip form on both sides with adjustable waist band/Fly For Men/Black
BSN-Jobst GmbH
77356-00023-00
In Commercial Distribution

  • 04019702303568 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 1/Arm sleeve with bias top end and glove, one piece/With Finger, with Thumb/Dotted Silicone band inside/Caramel
BSN-Jobst GmbH
77328-00045-00
In Commercial Distribution

  • 04019702299588 ()

  • Pressure: 15-21 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 1/Arm sleeve with bias top end and glove, one piece/With Finger, with Thumb/Dotted Silicone band inside/Black
BSN-Jobst GmbH
77328-00030-00
In Commercial Distribution

  • 04019702298956 ()

  • Pressure: 15-21 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX 1/ARM SLEEVE BIAS TOP END AND GLOVE, 1 PIECE/WITH FINGER, WITH THUMB/DOTTED SILICONE BAND INSIDE, WITH ZIPPER
BSN-Jobst GmbH
77328-00036-00
In Commercial Distribution

  • 04019702298895 ()

  • Pressure 15-21 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Arm sleeve to axilla with glove, one piece/With Finger, with Thumb/Dotted 5 cm Silicone Band on Top
BSN-Jobst GmbH
77360-00005-00
In Commercial Distribution

  • 04019702338997 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX 2/ARM SLEEVE TO AXILLA WITH GLOVE, ONE PIECE/WITH FINGER, WITH THUMB/DOTTED 2,5 CM SILICONE BAND ON TOP
BSN-Jobst GmbH
77360-00023-00
In Commercial Distribution

  • 04019702338812 ()

  • Pressure 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX 1/BODY BAND WITHOUT LEG EXTENSION/WITH SLIP FORM ON BOTH SIDES WITH ADJUSTABLE WAIST BAND/FOR MAN WITH FLY-ZIPPER
BSN-Jobst GmbH
77322-00026-00
In Commercial Distribution

  • 04019702317282 ()

  • Pressure 18-21 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 1/Body Bandage with Leg Extension/with slip form on both sides with adjustable waist band/Fly For Men/Black
BSN-Jobst GmbH
77323-00019-00
In Commercial Distribution

  • 04019702316193 ()

  • Pressure: 18-21 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 3/Body Bandage with Leg Extension/with slip form on both sides with adjustable waist band/Fly For Men/Black
BSN-Jobst GmbH
77388-00021-00
In Commercial Distribution

  • 04019702341218 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Arm sleeve with bias top end and glove, one piece/With Finger, with Thumb/Dotted Silicone band inside/Caramel
BSN-Jobst GmbH
77361-00045-00
In Commercial Distribution

  • 04019702338683 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Arm sleeve with bias top end and glove, one piece/With Finger, with Thumb/Dotted Silicone band inside/Black
BSN-Jobst GmbH
77361-00031-00
In Commercial Distribution

  • 04019702337976 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX 1/BODY BANDAGE WITH LEG EXTENSION/WITH SLIP FORM ON BOTH SIDES WITH ADJUSTABLE WAIST BAND/FOR MAN-NO FLY/CRANBERRY
BSN-Jobst GmbH
77323-00582-00
In Commercial Distribution

  • 04059993088911 ()

  • Pressure 18-21 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX FORTE 3/BODY BANDAGE WITH LEG EXTENSION/WITH SLIP FORM ON BOTH SIDES WITH ADJUSTABLE WAIST BAND/FOR MAN-NO FLY
BSN-Jobst GmbH
77441-00463-00
In Commercial Distribution

  • 04059993061815 ()

  • Pressure 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX 2/BODY BANDAGE WITH LEG EXTENSION/WITH SLIP FORM ON BOTH SIDES WITH ADJUSTABLE WAIST BAND/FOR MAN-NO FLY/BLACK
BSN-Jobst GmbH
77356-00587-00
In Commercial Distribution

  • 04059993098583 ()

  • Pressure 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX 3/BODY BANDAGE WITH LEG EXTENSION/WITH SLIP FORM ON BOTH SIDES WITH ADJUSTABLE WAIST BAND/FOR MAN-NO FLY/BLACK
BSN-Jobst GmbH
77388-00549-00
In Commercial Distribution

  • 04059993094189 ()

  • Pressure 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX 1/BODY BANDAGE WITH LEG EXTENSION/WITH SLIP FORM ON BOTH SIDES WITH ADJUSTABLE WAIST BAND/FOR MAN-NO FLY/BLACK
BSN-Jobst GmbH
77323-00540-00
In Commercial Distribution

  • 04059993091157 ()

  • Pressure 18-21 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX 1/BODY BANDAGE WITH LEG EXTENSION/WITH SLIP FORM ON BOTH SIDES WITH ADJUSTABLE WAIST BAND/FOR MAN-NO FLY/GRAPHITE
BSN-Jobst GmbH
77323-00656-00
In Commercial Distribution

  • 04059993089659 ()

  • Pressure 18-21 mmHg


  • Compression/pressure sock/stocking, reusable
ThermiSense® Nasal Air Flow Pressure Cannula (Adult) with Thermistor Holder 7' (2.1 m) tube with male/female adaptor with filter.
SALTER LABS
5750-7
In Commercial Distribution

  • 20607411301241 ()
  • 10607411301244 ()
  • 00607411301247 ()

  • Adult
5750-7

  • Respiratory apnoea monitoring system
ECG Input Cable White with 10kOhm Resistors and dedicated ODU Plug with AHA color coding to 3 Leads with Clip connectors
Norav Medical GmbH
C3-C-U-LL-ODUR-W
In Commercial Distribution

  • 04260498565993 ()
C3-C-U-LL-ODUR-W

  • Electrocardiographic lead set, reusable
MICROBORE INFUSION SET WITH FEMALE LUER LOCK, ADMINISTRATION CASSETTE WITH FREE-FLOW PROTECTION, SLIDE CLAMP AND ONE-WAY CHECKVALVE WITH MALE LUER LOCK
EITAN MEDICAL LTD
12222-000-0004
In Commercial Distribution

  • 17290109152506 ()
  • 27290109152503 ()


  • Electric infusion pump administration set, single-use
PowerPort duo M.R.I. Implantable Port with Attachable 9.5F ChronoFlex Open-Ended Dual-Lumen Venous Catheter with Smooth Septum. Intermediate Kit (with Suture Plugs)
Bard Access Systems, Inc.
5829502
In Commercial Distribution

  • 10801741027403 ()
  • 00801741027406 ()

  • Catheter Gauge: 9.5 French
  • Length: 45 Centimeter
5829502

  • Vascular port/catheter
The M5, Single Package with Single Flat Panel Monitor Mount, with Hub, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191405 ()
LM24T

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The M5, Single Package with Single Flat Panel Monitor Mount, with Hub Spacer is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191399 ()
LM24

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The M7 Single Package with Single High Density Flat Panel Monitor with Hub is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995190460 ()
LM29N

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
Proprietary bio-compatible patch electrode array with nine Ag/AgCl pads lined with hydrogel. Intended to be used with TrueLabor Maternal Unit.
O.B - TOOLS LTD
FG0003(X)
Not in Commercial Distribution

  • 07290016406030 ()
  • 17290016406037 ()
  • 27290016406034 ()

  • Width: 280 Millimeter
  • Length: 320 Millimeter
FG0003(X)

  • Cardiotocography telemetric monitoring system
Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port with Sharps Safety Features for use with 7.5 - 8 Fr. Catheters
TELEFLEX INCORPORATED
IPN035917
In Commercial Distribution

  • 30801902028137 ()
  • 00801902028136 ()
RH-09901

  • Vascular catheter introduction set, nonimplantable
With Fluid Ciculation - Thermal Balloon Ablation Silicone Catheter with Fluid Circulation. For use only with GYNECARE THERMACHOICE TM UBT System Controller
Ethicon Inc.
TC003
Not in Commercial Distribution

  • 20705031050737 ()
  • 10705031050730 ()
TC003

  • Circulating-fluid endometrial-ablation catheter
Safety blood collection set with pre-attached holder, 23G*3/4" with 12" tubing
KB Medical (group), Inc.
SBCN23-1H
In Commercial Distribution

  • 00850016172372 ()


  • Blood collection set, invasive
Safety blood collection set with pre-attached holder, 21G*3/4" with 12" tubing
KB Medical (group), Inc.
SBCN21-1H
In Commercial Distribution

  • 00850016172341 ()


  • Blood collection set, invasive
Safety blood collection set with pre-attached holder, 25G*3/4" with 12" tubing
KB Medical (group), Inc.
SBCN25-1H
In Commercial Distribution

  • 00850016172969 ()


  • Blood collection set, invasive
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