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 sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
LL- 1ml 25G X 1 1/2"
In Commercial Distribution

  • 16958697602568 ()
  • 06958697602561 ()
  • 26958697602565 ()
SLL1N2538

  • Metered-delivery hypodermic syringe
A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
LS - 1ml 25G X 1 1/2"
In Commercial Distribution

  • 16958697602551 ()
  • 06958697602554 ()
  • 26958697602558 ()
SLS1N2538

  • Metered-delivery hypodermic syringe
A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
LL - 1ml 25G X 1"
In Commercial Distribution

  • 16958697602544 ()
  • 06958697602547 ()
  • 26958697602541 ()
SLL1N2525

  • Metered-delivery hypodermic syringe
A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
LS - 1ml 25G X 1"
In Commercial Distribution

  • 16958697602537 ()
  • 06958697602530 ()
  • 26958697602534 ()
SLS1N2525

  • Metered-delivery hypodermic syringe
A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
LL - 3ml 23G X 1"
In Commercial Distribution

  • 16958697602520 ()
  • 06958697602523 ()
  • 26958697602527 ()
T3ML2325E

  • Metered-delivery hypodermic syringe
A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
LS - 1ml 23G X 1"
In Commercial Distribution

  • 16958697602421 ()
  • 06958697602424 ()
  • 26958697602428 ()
SLS1N2325

  • Metered-delivery hypodermic syringe
A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
LL - 1ml 23G X 1"
In Commercial Distribution

  • 16958697602797 ()
  • 06958697602790 ()
  • 26958697602794 ()
SLL1N2325

  • Metered-delivery hypodermic syringe
Suture
RIVERPOINT MEDICAL, LLC
110045781
In Commercial Distribution

  • 00810020088311 ()


  • Polyolefin/fluoropolymer suture, multifilament
Suture
RIVERPOINT MEDICAL, LLC
110045780
In Commercial Distribution

  • 00810020088304 ()


  • Polyolefin/fluoropolymer suture, multifilament
Suture Tape
RIVERPOINT MEDICAL, LLC
110045779
In Commercial Distribution

  • 00810020088298 ()


  • Polyolefin/fluoropolymer suture, multifilament
Suture Tape
RIVERPOINT MEDICAL, LLC
110045778
In Commercial Distribution

  • 00810020088281 ()


  • Polyolefin/fluoropolymer suture, multifilament
Suture
RIVERPOINT MEDICAL, LLC
110045777
In Commercial Distribution

  • 00810020088274 ()


  • Polyolefin/fluoropolymer suture, multifilament
Suture
RIVERPOINT MEDICAL, LLC
110045776
In Commercial Distribution

  • 00810020088267 ()


  • Polyolefin/fluoropolymer suture, multifilament
Affinity is a device used to clean a tissue (skin) by tiny jets of sterile fluid
TAVGER LTD
FG00004
In Commercial Distribution

  • 07290017249001 ()


  • Surgical/orthopaedic lavage control unit
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
0010-30-12161
In Commercial Distribution

  • 06944904003948 ()


  • Blood pressure cuff, reusable
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
0010-30-12159
In Commercial Distribution

  • 06944904003924 ()


  • Blood pressure cuff, reusable
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
0010-30-12158
In Commercial Distribution

  • 06944904003917 ()


  • Blood pressure cuff, reusable
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
0010-30-12157
In Commercial Distribution

  • 06944904003900 ()


  • Blood pressure cuff, reusable
No Description
Hunan Vathin Medical Instrument Co., Ltd
MET-A2
In Commercial Distribution

  • 06972197480900 ()


  • Examination/operating table component trolley
Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient. Package size 2 x 2800 ml
Xvivo Perfusion AB
19018
Not in Commercial Distribution

  • 07350069520067 ()
19018

  • Donor-organ/tissue/cell preservation solution
Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient. Package size: 8x 1000 ml
Xvivo Perfusion AB
19017
Not in Commercial Distribution

  • 07350069520050 ()
19017

  • Donor-organ/tissue/cell preservation solution
No Description
Biomet Orthopedics, LLC
25-012
In Commercial Distribution

  • 00887868074127 ()
25012

  • Bone tap, reusable
No Description
CAPTIVA SPINE, INC.
CP50120
In Commercial Distribution

  • M739CP50120 ()


  • Surgical screwdriver, reusable
REFURBCANNULA5.5MM OPER. W/O STPCK
Smith & Nephew, Inc.
7205367D
Not in Commercial Distribution

  • 00885556567807 ()
7205367D

  • Surgical drill guide, reusable
No Description
ELECTRO-CAP INTERNATIONAL INC
E2S-22WIRE
In Commercial Distribution

  • 00811478011739 ()
E2S-22WIRE

  • Analytical scalp lead
No Description
ELECTRO-CAP INTERNATIONAL INC
E2S
In Commercial Distribution

  • 00811478011593 ()
E2S

  • Analytical scalp lead
AnchorSeed/TSL in FlatPack – 15 stranded seeds per mag– STERILE
THERAGENICS CORPORATION
XX77315iF
In Commercial Distribution

  • 00813787021331 ()


  • Manual brachytherapy source, permanent implant
AnchorSeed/TSL in TPSII Ind.– 15 stranded seeds per mag- STERILE
THERAGENICS CORPORATION
XX77315iN
In Commercial Distribution

  • 00813787021324 ()


  • Manual brachytherapy source, permanent implant
VariStrand with OncoSeed, x = 1-12 seeds and 0 or more spacers
THERAGENICS CORPORATION
ON772xi
In Commercial Distribution

  • 00813787021232 ()


  • Manual brachytherapy source, permanent implant
VariStrand with x = 1-12 seeds and 0 or more spacers
THERAGENICS CORPORATION
XX772xi
In Commercial Distribution

  • 00813787021171 ()


  • Manual brachytherapy source, permanent implant
AnchorLoad with x = 1-12 seeds and 0 or more spacers
THERAGENICS CORPORATION
XX782xi
In Commercial Distribution

  • 00813787021157 ()


  • Manual brachytherapy source, permanent implant
AnchorSeed in Flatpack – 15 stranded seeds per mag- STERILE
THERAGENICS CORPORATION
XX77215iF
In Commercial Distribution

  • 00813787021133 ()


  • Manual brachytherapy source, permanent implant
AnchorSeed in TPSII Ind.– 15 stranded seeds per mag- STERILE
THERAGENICS CORPORATION
XX77215iN
In Commercial Distribution

  • 00813787021119 ()


  • Manual brachytherapy source, permanent implant
Adapter, Flushing with Luer Lock with holding-strap ValveGate™
Geister Medizintechnik GmbH
34-7499B
In Commercial Distribution

  • 04057034120903 ()
34-7499B

  • Heart valve annulus sizer, reusable
Retractor, Spinal, ring-handle with double-hinge with catch PEEK SpineControl™
Geister Medizintechnik GmbH
29-3100.PK
In Commercial Distribution

  • 04057034098042 ()
29-3100.PK

  • Surgical retraction system mounting frame, reusable
Retractor, Spinal, ring-handle with double-hinge with catch SpineControl™
Geister Medizintechnik GmbH
29-3100
In Commercial Distribution

  • 04057034098035 ()
29-3100

  • Surgical retraction system mounting frame, reusable
This instrument is used to grasp, retract, or stabilize tissue.
DAUD JEE MFG. CO
DT50-500095-1
In Commercial Distribution

  • G006DT5050009510 ()
DT50-500095-1

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
This instrument is used to grasp, retract, or stabilize tissue.
DAUD JEE MFG. CO
DT50-500095
In Commercial Distribution

  • G006DT505000950 ()
DT50-500095

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
No Description
Lonza Walkersville, Inc.
12-743F
In Commercial Distribution

  • 00840075402831 ()
12-743F

  • Ex vivo cell culture medium
The Rabbit FluoroDetector FITC with FluoroMounter with DAPI kit is intended for the detection of antigens in paraffin-embedded tissue, cryostat sections, blood smears, cytosmears, and cell preparations
BIO SB, INC.
100 ml
In Commercial Distribution

  • B502BSB03200 ()
BSB 0320

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
The Rabbit FluoroDetector FITC with FluoroMounter with DAPI kit is intended for the detection of antigens in paraffin-embedded tissue, cryostat sections, blood smears, cytosmears, and cell preparations
BIO SB, INC.
50 ml
In Commercial Distribution

  • B502BSB03190 ()
BSB 0319

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
The Rabbit FluoroDetector FITC with FluoroMounter with DAPI is intended for the detection of antigens in paraffin-embedded tissue, cryostat sections, blood smears, cytosmears, and cell preparations
BIO SB, INC.
15 ml
In Commercial Distribution

  • B502BSB03180 ()
BSB 0318

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
ACUMEN IQ SENSOR 60'' / 152CM WITH FLUID METER WITH VAMP WITH TRUWAVE 5-PACK
Edwards Lifesciences LLC
AIQSFM6C502
In Commercial Distribution

  • 50690103205836 ()
  • 00690103205831 ()
AIQSFM6C502

  • Intravenous line sensor, gravity infusion
SonoVision Accessory Kit Second Dilator
Tissue Differentiation Intelligence LLC
100034
In Commercial Distribution

  • 00860001239386 ()


  • Interventional radiology percutaneous-access kit, reusable
SonoVision Accessory Kit Initial Dilator
Tissue Differentiation Intelligence LLC
100033
In Commercial Distribution

  • 00860001239379 ()


  • Interventional radiology percutaneous-access kit, reusable
SonoVision Accessory Kit Dilator Guide - Double
Tissue Differentiation Intelligence LLC
100030
In Commercial Distribution

  • 00860001239362 ()


  • Interventional radiology percutaneous-access kit, reusable
Beluga1 Imaging Probe
Tissue Differentiation Intelligence LLC
100005
In Commercial Distribution

  • 00860001239348 ()


  • Surgical ultrasound imaging transducer
SonoVision Accessory Kit Dilator Guide - Triple
Tissue Differentiation Intelligence LLC
100022
In Commercial Distribution

  • 00860001239331 ()


  • Interventional radiology percutaneous-access kit, reusable
SonoVision Accessory Kit Stabilzer Tube
Tissue Differentiation Intelligence LLC
100021
In Commercial Distribution

  • 00860001239324 ()


  • Interventional radiology percutaneous-access kit, reusable
SHEATH 990065 FLEXCATH SELECT 10 FR 65CM
MEDTRONIC, INC.
990065
Not in Commercial Distribution

  • 00643169688858 ()

  • Usable length 65 cm
  • Dilator inner diameter 1 mm
  • Sheath inner diameter 10 Fr (3.3 mm)


  • Haemostasis valve
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