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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Elvarex 3/Thigh High/Slant-Open Toe/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77567-00219-00
In Commercial Distribution

  • 04019702292534 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 1/Mid Thigh High/Closed Toe/Thigh high without volant to sew at body bandage/Black
BSN-Jobst GmbH
77309-00054-00
In Commercial Distribution

  • 04019702312447 ()

  • Pressure: 18-21 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 1/Thigh High/Closed Toe/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77310-00176-00
In Commercial Distribution

  • 04019702311891 ()

  • Pressure: 18-21 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 1/Thigh High/Open Toe/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77310-00180-00
In Commercial Distribution

  • 04019702311877 ()

  • Pressure: 18-21 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 1/Thigh High/Slant-Open Toe/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77310-00195-00
In Commercial Distribution

  • 04019702311792 ()

  • Pressure: 18-21 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 1/Thigh High/Slant-Closed Toe/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77310-00198-00
In Commercial Distribution

  • 04019702311785 ()

  • Pressure: 18-21 mmHg


  • Compression/pressure sock/stocking, reusable
Lester fixation forceps, 3 3/4'', straight shafts, fine 2x3 teeth set at 90 degrees, flat handle
AMBLER SURGICAL CORP.
Lester fixation forceps
In Commercial Distribution

  • 00190660060992 ()
2263E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Lester fixation forceps, 3 3/4'', straight shafts, fine 1x2 teeth set at 90 degrees, flat handle
AMBLER SURGICAL CORP.
Lester fixation forceps
In Commercial Distribution

  • 00190660060985 ()
2262E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Cushing-Brown Bayonet Tissue Forceps, 7" (180mm), 8 x 8 side grasping teeth, non-conductive, exposed at both ends
Hayden Medical, Inc.
120-170NC
In Commercial Distribution

  • 00840319739785 ()
120-170NC

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
knolle-pearce irrigating lens loop, irrigating ports at 12, 10 & 2 o'clock, 23-gauge, 1 1/4" (3.0 cm)
NOVO SURGICAL, INC.
OP7123-66
In Commercial Distribution

  • 00842331181795 ()
OP7123-66

  • Surgical fluid/gas irrigator
Breast Retractor w/Suction 4cm blade w/teeth at 90 degree angle, 4.0mm suction tube 12 FR
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
ASSI.ABR55626
In Commercial Distribution

  • 00841645124665 ()


  • Hand-held surgical retractor, reusable
Colour touch screen T272HLbmjjz 27 Full HD (1080p) 1920 x 1080 at 60 Hz for Zirkonzahn scanner
ZIRKONZAHN SRL
KTAP0273
In Commercial Distribution

  • D800KTAP0273 ()


  • Dental milling system, CAD/CAM, laboratory
Exchangeable suction-Irrigation tube M8 x 1, Ø 10mm, markings and 4 holes at distal end OlympusID: A5797
Pajunk GmbH Medizintechnologie
1298-00-10OL
Not in Commercial Distribution

  • 04048223029541 ()
1298-00-10OL

  • Laparoscopic access cannula, reusable
Exchangeable suction-Irrigation tube M8 x 1, Ø 5mm, markings and 4 holes at distal end Olympus-ID: A5798
Pajunk GmbH Medizintechnologie
1298-00-05OL
Not in Commercial Distribution

  • 04048223029534 ()
1298-00-05OL

  • Laparoscopic access cannula, reusable
Exchangeable suction-Irrigation tube M8 x 1, Ø 3mm, markings and 4 holes at distal end; Olympus-ID: A5799
Pajunk GmbH Medizintechnologie
1298-00-03OL
Not in Commercial Distribution

  • 04048223029527 ()
1298-00-03OL

  • Laparoscopic access cannula, reusable
GOLDSTEIN Glenoid Neck Retractor 18 mm wide tip at teeth, 21.5 cm, 8 1/2" overall length
RZ-Medizintechnik GmbH
259-258-400
In Commercial Distribution

  • 04049197454193 ()
259-258-400

  • Hand-held surgical retractor, reusable
V. Mueller COAKLEY ANTRUM TROCAR & WASH TUBE 13GA AT TIP, TAPERS TO 19GA OVERALL LENGTH 6" (15.2CM)
CAREFUSION 2200, INC
RH2980
Not in Commercial Distribution

  • 10885403114366 ()
RH2980

  • ENT trocar blade
HASSON AUTOM. TROCAR W. SUTUREHOLDER FIXED AT CONE 11 MM, STOP-COCK FOR INSUFFLATION, TROCAR MANDRIN BLUNT TIP
Gimmi GmbH
T.8014.41
In Commercial Distribution

  • 04049047103899 ()
T.8014.41

  • Laparoscopic access cannula, reusable
HASSON AUTOM. TROCAR W. SUTUREHOLDER FIXED AT CONE 5.5 MM, STOP-COCK FOR INSUFFLATION, TROCAR MANDRIN BLUNT TIP
Gimmi GmbH
T.8014.36
In Commercial Distribution

  • 04049047103875 ()
T.8014.36

  • Laparoscopic access cannula, reusable
microTargeting™ MR Lead Insertion Tube 1 mm above target with Ceramic Stylet at target, non-sterile, 2x
FHC, INC.
66-IT-MR3-00807
In Commercial Distribution

  • 10873263008079 ()
  • 00873263008072 ()

  • Lumen/Inner Diameter: 1.6 Millimeter
  • Outer Diameter: 1.8 Millimeter
  • Length: 210.85 Millimeter
66-IT-MR3

  • Intracerebral cannula, nonimplantable, single-use
V. Mueller Neuro/Spine MULTI-HOLE SUCTION TUBE 5 HOLES AT TIP WORKING LENGTH 9 inches 235MM 5FR
STERIS CORPORATION
G-0050
In Commercial Distribution

  • 10885403041723 ()
G0050

  • Surgical/emergency suction cannula, non-illuminating, reusable
knee high boot covers (45g SMS + SMS Glue Grip dots non skid bottoms, elastic at ankle) [EMS-11211B]
Emergency Medical Solutions LLC
EMS-11211B
In Commercial Distribution

  • 20376885018015 ()
  • 00376885018011 ()


  • Shoe cover
Symmetry® Caliper, Austin Strut, Markers At 3.5 mm, 4 mm & 4.5 mm From Tip, 6 in
SYMMETRY SURGICAL INC.
61-0310
In Commercial Distribution

  • 00887482113387 ()

  • Length: 6 Inch
61-0310

  • General-purpose calliper, metallic
Elvarex 4/Thigh High/Profile-Slant-Open Toe/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77408-00113-00
In Commercial Distribution

  • 04019702326208 ()

  • Pressure: >49 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 4/Thigh High/Open Toe/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77408-00069-00
In Commercial Distribution

  • 04019702325737 ()

  • Pressure: >49 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 4/Thigh High/Closed Toe/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77408-00073-00
In Commercial Distribution

  • 04019702325713 ()

  • Pressure: >49 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 4/Thigh High/Slant-Open Toe/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77408-00077-00
In Commercial Distribution

  • 04019702325690 ()

  • Pressure: >49 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 4/Thigh High/Slant-Closed Toe/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77408-00081-00
In Commercial Distribution

  • 04019702325676 ()

  • Pressure: >49 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 4/Thigh High/Profile-Open Toe/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77408-00084-00
In Commercial Distribution

  • 04019702325652 ()

  • Pressure: >49 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Thigh High/Slant-Closed Toe-Elephantiasis-Version/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77556-00474-00
In Commercial Distribution

  • 04019702251043 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Thigh High/Slant-Open Toe-Elephantiasis-Version/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77556-00514-00
In Commercial Distribution

  • 04019702250060 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Thigh High/Closed Toe/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77556-00228-00
In Commercial Distribution

  • 04019702249569 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Thigh High/Slant-Open Toe/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77556-00232-00
In Commercial Distribution

  • 04019702249545 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Thigh High/Slant-Closed Toe/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77556-00236-00
In Commercial Distribution

  • 04019702249521 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Thigh High/Closed Toe-Elephantiasis-Version/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77556-00320-00
In Commercial Distribution

  • 04019702248890 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Thigh High/Open Toe-Elephantiasis-Version/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77556-00354-00
In Commercial Distribution

  • 04019702248692 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Thigh High/Profile-Closed Toe/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77556-00296-00
In Commercial Distribution

  • 04019702248258 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Thigh High/Profile-Slant-Open Toe/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77556-00298-00
In Commercial Distribution

  • 04019702248234 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Thigh High/Open Toe/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77556-00223-00
In Commercial Distribution

  • 04019702181135 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 3/Mid Thigh High/Slant-Closed Toe-Elephantiasis-Version/Thigh high without volant to sew at body bandage/Black
BSN-Jobst GmbH
77372-00653-00
In Commercial Distribution

  • 04019702533637 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 4 Super/Thigh High/Open Toe/Thigh high without volant to sew at body bandage/Black
BSN-Jobst GmbH
77453-00231-00
In Commercial Distribution

  • 04019702507638 ()

  • Pressure: >49 mmHg


  • Compression/pressure sock/stocking, reusable
Secto® Handle, Laparoscopic, (SGH10 at 20 cm WL), Short, 10 mm, 20.5 cm Working Length, Reusable
SYMMETRY SURGICAL INC.
SGH1032
Not in Commercial Distribution

  • 00887482155745 ()


  • Laparoscopic surgery handle
Lewicky Cortex Extractor 23ga, Curved shaft, .3mm Aspirating Port set at 45 Degree right, 13mm Overall Length
Crestpoint Management Limited
CA270
In Commercial Distribution

  • G412CA2700 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Lewicky Cortex Extractor 23ga, Curved shaft, .3mm Aspirating Port set at 45 Degree left, 13mm Overall Length
Crestpoint Management Limited
CA265
In Commercial Distribution

  • G412CA2650 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Sheets Irrigation Vectis 20ga loop with with 14ga Reinforced shaft, Angled 19mm from bend to tip at 20 degrees, Three Outer Irrigating Ports at 12, 9, and 3 o'clock, Serrated on top of Vectus, 38mm Overall Length
Crestpoint Management Limited
CA790
In Commercial Distribution

  • G412CA7900 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Gravity Compensating Accessory, Low Pressure Range (White)
NATUS MEDICAL INCORPORATED
NT903430
In Commercial Distribution


  • Additional Resistance to Flow at 5ml/h, Horizontal Orientation < 30mmH2O, Vertical Orientation: 140-170mmH2O
NT903430

  • Ventriculo-peritoneal/atrial shunt
Gravity Compensating Accessory, Medium Pressure Range (Yellow)
NATUS MEDICAL INCORPORATED
NT903435
In Commercial Distribution


  • Additional Resistance to Flow at 5ml/h, Horizontal Orientation < 30mmH2O, Vertical Orientation: 200-250mmH2O
NT903435

  • Ventriculo-peritoneal/atrial shunt
RENASYS EDGE Carry Straps
SMITH & NEPHEW MEDICAL LIMITED
66803137
In Commercial Distribution

  • 05000223501150 ()
  • 05000223501143 ()

  • 42x135x12 milimeter W x H x D (approximate dimensions with strap at longest)
66803137

  • Negative-pressure wound therapy system, electric, reusable
The Gravity Compensating Accessory (GCA) is designed to counterbalance gravity’s effects on the fluid column within the drainage catheter of an implanted shunt system. The GCA consists of a silicone elastomer encased stainless steel housing with a ruby ball held in a stainless steel seat (in the vertical orientation) by two to four stainless steel balls. In the horizontal orientation, a minimal resistance to flow (<30mmH2O at 5ml/h) is added to the system, and in the vertical orientation: 140-170, 200-250 or 260-320mmH2O (at 5ml/h).
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
903435
Not in Commercial Distribution

  • 10381780033523 ()
  • M2729034351 ()

  • Additional Resistance to Flow at 5ml/h, Horizontal Orientation < 30mmH2O, Vertical Orientation: 200-250mmH2O
903435

  • Ventriculo-peritoneal/atrial shunt
The Gravity Compensating Accessory (GCA) is designed to counterbalance gravity’s effects on the fluid column within the drainage catheter of an implanted shunt system. The GCA consists of a silicone elastomer encased stainless steel housing with a ruby ball held in a stainless steel seat (in the vertical orientation) by two to four stainless steel balls. In the horizontal orientation, a minimal resistance to flow (<30mmH2O at 5ml/h) is added to the system, and in the vertical orientation: 140-170, 200-250 or 260-320mmH2O (at 5ml/h).
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
903430
Not in Commercial Distribution

  • 10381780033516 ()
  • M2729034301 ()

  • Additional Resistance to Flow at 5ml/h, Horizontal Orientation < 30mmH2O, Vertical Orientation: 140-170mmH2O
903430

  • Ventriculo-peritoneal/atrial shunt
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