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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1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS85-35-81-135-D1
Not in Commercial Distribution

  • 00685447003717 ()

  • 81cm 8.5F VersaCross Transseptal Sheath with 135° curve; 85cm 8.5F VersaCross Transseptal Dilator with Large Curve D1; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use
1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS85-35-81-90-D1
Not in Commercial Distribution

  • 00685447003700 ()

  • 81cm 8.5F VersaCross Transseptal Sheath with 90° curve; 85cm 8.5F VersaCross Transseptal Dilator with Large Curve D1; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use
1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS85-35-81-55-D1
Not in Commercial Distribution

  • 00685447003694 ()

  • 81cm 8.5F VersaCross Transseptal Sheath with 55° curve; 85cm 8.5F VersaCross Transseptal Dilator with Large Curve D1; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use
1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS85-35-81-45-D1
In Commercial Distribution

  • 00685447003687 ()

  • 81cm 8.5F VersaCross Transseptal Sheath with 45° curve; 85cm 8.5F VersaCross Transseptal Dilator with Large Curve D1; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use
1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS85-35-81-37-D1
Not in Commercial Distribution

  • 00685447003670 ()

  • 81cm 8.5F VersaCross Transseptal Sheath with 37° curve; 85cm 8.5F VersaCross Transseptal Dilator with Large Curve D1; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use
1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS8-35-81-135-D1
Not in Commercial Distribution

  • 00685447003663 ()

  • 81cm 8F VersaCross Transseptal Sheath with 135° curve; 85cm 8F VersaCross Transseptal Dilator with Large Curve D1; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use
1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS8-35-81-90-D1
Not in Commercial Distribution

  • 00685447003656 ()

  • 81cm 8F VersaCross Transseptal Sheath with 90° curve; 85cm 8F VersaCross Transseptal Dilator with Large Curve D1; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use
1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS8-35-81-55-D1
Not in Commercial Distribution

  • 00685447003649 ()

  • 81cm 8F VersaCross Transseptal Sheath with 55° curve; 85cm 8F VersaCross Transseptal Dilator with Large Curve D1; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use
1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS8-35-81-45-D1
Not in Commercial Distribution

  • 00685447003632 ()

  • 81cm 8F VersaCross Transseptal Sheath with 45° curve; 85cm 8F VersaCross Transseptal Dilator with Large Curve D1; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use
1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS8-35-81-37-D1
Not in Commercial Distribution

  • 00685447003625 ()

  • 81cm 8F VersaCross Transseptal Sheath with 37° curve; 85cm 8F VersaCross Transseptal Dilator with Large Curve D1; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use
1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS85-35-63-135-D1
Not in Commercial Distribution

  • 00685447003618 ()

  • 63cm 8.5F VersaCross Transseptal Sheath with 135° curve; 67cm 8.5F VersaCross Transseptal Dilator with Large Curve D1; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use
1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS85-35-63-90-D1
In Commercial Distribution

  • 00685447003601 ()

  • 63cm 8.5F VersaCross Transseptal Sheath with 90° curve; 67cm 8.5F VersaCross Transseptal Dilator with Large Curve D1; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use
1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS85-35-63-55-D1
In Commercial Distribution

  • 00685447003595 ()

  • 63cm 8.5F VersaCross Transseptal Sheath with 55° curve; 67cm 8.5F VersaCross Transseptal Dilator with Large Curve D1; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use
1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS85-35-63-45-D1
In Commercial Distribution

  • 00685447003588 ()

  • 63cm 8.5F VersaCross Transseptal Sheath with 45° curve; 67cm 8.5F VersaCross Transseptal Dilator with Large Curve D1; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use
1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS85-35-63-37-D1
Not in Commercial Distribution

  • 00685447003571 ()

  • 63cm 8.5F VersaCross Transseptal Sheath with 37° curve; 67cm 8.5F VersaCross Transseptal Dilator with Large Curve D1; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use
1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS8-35-63-135-D1
Not in Commercial Distribution

  • 00685447003564 ()

  • 63cm 8F VersaCross Transseptal Sheath with 135° curve; 67cm 8F VersaCross Transseptal Dilator with Large Curve D1; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use
1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS8-35-63-90-D1
Not in Commercial Distribution

  • 00685447003557 ()

  • 63cm 8F VersaCross Transseptal Sheath with 90° curve; 67cm 8F VersaCross Transseptal Dilator with Large Curve D1; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use
1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS8-35-63-55-D1
Not in Commercial Distribution

  • 00685447003540 ()

  • 63cm 8F VersaCross Transseptal Sheath with 55° curve; 67cm 8F VersaCross Transseptal Dilator with Large Curve D1; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use
1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS8-35-63-45-D1
Not in Commercial Distribution

  • 00685447003533 ()

  • 63cm 8F VersaCross Transseptal Sheath with 45° curve; 67cm 8F VersaCross Transseptal Dilator with Large Curve D1; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use
54 Unit Mining First Aid Kit - Contains: Adhesive Plastic Bandages, 1" x 3", 16 ct; Aluminized Rescue Blanket, 52" x 84"; Ammonia Inhalants, 20 ct; First Aid Guide; First Aid/Burn Cream Packets, 12 ct; Hema-Flex Bandage Compress, 2", 8 ct; Hema-Flex Bandage Compress, 4", 8 ct; Padded Flexible Splint, 4" x 24"; Stretch Tourniquet, 1" x 18", 2 ct; Triangular Bandage, 40" x 40" x 56", 24 ct; Triple Antibiotic Ointment Packets, 12 ct.
Acme United Corporation
90795
In Commercial Distribution

  • 00092265907958 ()
90795

  • First aid kit, medicated
Hardy Bayonet Bipolar Forcep 8 1/2" (215.9mm) With A Working Length Of 4 1/2" (114.30mm) With A With A 0.7mm Tip With Stop
TITAN MANUFACTURING INC
163010145040101
In Commercial Distribution

  • 00817914020808 ()

  • Length: 8.5 Inch


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Tebbetts Stainless Steel Fiber Optic Retractor, With Comfort Grip 90mm x 24mm Blade. With Teeth to Help With Tissue Slippage, With Smoke Evacuation Suction Tube
Med Saver, Inc.
220-2080-090T
In Commercial Distribution

  • 00194613099145 ()


  • Fibreoptic retractor handle
HANDLE PISTOL SHAPED MONO with locking mechanism, with turning wheel for insert rotation, with monopolar HF connection, for use with DUORotate / InLine sheath tubes, reusable
Richard Wolf GmbH
8399302
Not in Commercial Distribution

  • 04055207016923 ()
8399302

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Elvarex 3/Body Bandage with Leg Extension/with slip form on both sides with adjustable waist band/Black
BSN-Jobst GmbH
77388-00020-00
In Commercial Distribution

  • 04019702341201 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Arm sleeve with shoulder cap and glove, one piece/Shoulder Strap, with Finger, with Thumb/Caramel
BSN-Jobst GmbH
77362-00054-00
In Commercial Distribution

  • 04019702340990 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Arm sleeve with shoulder cap and glove, one piece/Shoulder Strap, with Finger, with Thumb/Zipper
BSN-Jobst GmbH
77362-00013-00
In Commercial Distribution

  • 04019702340624 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Arm sleeve with shoulder cap and glove, one piece/Shoulder Strap, with Finger, with Thumb/Black
BSN-Jobst GmbH
77362-00036-00
In Commercial Distribution

  • 04019702340396 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Arm sleeve to axilla with glove, one piece/With Finger, with Thumb/Dotted Silicone band inside
BSN-Jobst GmbH
77360-00022-00
In Commercial Distribution

  • 04019702338829 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Arm sleeve with shoulder cap and glove, one piece/Bra strap withVelcro, with Finger, with Thumb
BSN-Jobst GmbH
77362-00001-00
In Commercial Distribution

  • 04019702338409 ()

  • 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/Black
BSN-Jobst GmbH
77323-00018-00
In Commercial Distribution

  • 04019702316186 ()

  • 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/ZIPPER
BSN-Jobst GmbH
77356-00028-00
In Commercial Distribution

  • 04019702303513 ()

  • Pressure 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 1/Arm sleeve with shoulder cap and glove, one piece/Bra strap withVelcro, with Finger, with Thumb
BSN-Jobst GmbH
77329-00001-00
In Commercial Distribution

  • 04019702299335 ()

  • Pressure: 15-21 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 1/Arm sleeve to axilla with glove, one piece/With Finger, with Thumb/Dotted Silicone band inside
BSN-Jobst GmbH
77327-00004-00
In Commercial Distribution

  • 04019702317923 ()

  • 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/ZIPPER
BSN-Jobst GmbH
77323-00026-00
In Commercial Distribution

  • 04019702316841 ()

  • Pressure 18-21 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX 1/BODY BANDAGE WITH LEG EXTENSION/WITH SLIP FORM ON ONE SIDE WITH ADJUSTABLE WAIST BAND/BLACK
BSN-Jobst GmbH
77323-00017-00
In Commercial Distribution

  • 04019702316179 ()

  • 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/Black
BSN-Jobst GmbH
77356-00022-00
In Commercial Distribution

  • 04019702303575 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 1/Arm sleeve with shoulder cap and glove, one piece/Shoulder Strap, with Finger, with Thumb/Zipper
BSN-Jobst GmbH
77329-00066-00
In Commercial Distribution

  • 04019702298680 ()

  • Pressure: 15-21 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 1/Arm sleeve with shoulder cap and glove, one piece/Shoulder Strap, with Finger, with Thumb/Black
BSN-Jobst GmbH
77329-00032-00
In Commercial Distribution

  • 04019702298246 ()

  • Pressure: 15-21 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex Forte 3/Body Bandage with Leg Extension/with slip form on both sides with adjustable waist band
BSN-Jobst GmbH
77441-00008-00
In Commercial Distribution

  • 04019702258745 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX 4/BODY BANDAGE WITH LEG EXTENSION/WITH SLIP FORM ON BOTH SIDES/FOR MAN WITH FLY/NAVY
BSN-Jobst GmbH
77419-00030-00
In Commercial Distribution

  • 04019702495577 ()

  • Pressure >49 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 1/Body Bandage with Leg Extension/with slip form on both sides with adjustable waist band/Navy
BSN-Jobst GmbH
77323-00050-00
In Commercial Distribution

  • 04019702485110 ()

  • Pressure: 18-21 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX 1/ARM SLEEVE WITH SHOULDER CAP AND GLOVE, ONE PIECE/SHOULDER STRAP, WITH FINGER, WITH THUMB/HONEY
BSN-Jobst GmbH
77329-00171-00
In Commercial Distribution

  • 04019702539790 ()

  • Pressure 15-21 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex Forte 2/Arm sleeve with shoulder cap and glove, one piece/Shoulder Strap, with Finger, with Thumb
BSN-Jobst GmbH
79585-00006-00
In Commercial Distribution

  • 04019702516081 ()

  • 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/Honey
BSN-Jobst GmbH
79583-00066-00
In Commercial Distribution

  • 04019702515206 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Sump-n-Sheath®, Sump Drain, Three Lumens, Silicone, Large Eye, With Silicone Penrose, With Suture Ring, With ClotStop®
AXIOM MEDICAL, INCORPORATED
111157AT
In Commercial Distribution

  • M665111157AT3 ()
  • M665111157AT1 ()
  • M665111157AT0 ()

  • Lumen/Inner Diameter: 0.625 Inch
  • Length: 20 Inch
  • Lumen/Inner Diameter: 9 Millimeter


  • Sump drain
Sump-n-Sheath®, Sump Drain, Two Lumens, Silicone, Large Eye, With Silicone Penrose, With Suture Ring, With ClotStop®
AXIOM MEDICAL, INCORPORATED
111156AT
In Commercial Distribution

  • M665111156AT3 ()
  • M665111156AT1 ()
  • M665111156AT0 ()

  • Lumen/Inner Diameter: 7 Millimeter
  • Length: 18 Inch
  • Lumen/Inner Diameter: 0.5 Inch


  • Sump drain
Sump-n-Sheath®, Sump Drain, Three Lumens, Silicone, Large Eye, With Silicone Penrose, With Suture Ring, With ClotStop®
AXIOM MEDICAL, INCORPORATED
111155AT
In Commercial Distribution

  • M665111155AT3 ()
  • M665111155AT1 ()
  • M665111155AT0 ()

  • Lumen/Inner Diameter: 0.625 Inch
  • Length: 14 Inch
  • Lumen/Inner Diameter: 9 Millimeter


  • Sump drain
ELVAREX 3/BODY BANDAGE WITH LEG EXTENSION/WITH SLIP FORM ON BOTH SIDES WITH ADJUSTABLE WAIST BAND/NAVY
BSN-Jobst GmbH
77388-00047-00
In Commercial Distribution

  • 04019702477108 ()

  • 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/Navy
BSN-Jobst GmbH
77356-00052-00
In Commercial Distribution

  • 04019702473247 ()

  • 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/Cocoa
BSN-Jobst GmbH
77323-00072-00
In Commercial Distribution

  • 04019702434262 ()

  • Pressure: 18-21 mmHg


  • Compression/pressure sock/stocking, reusable
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