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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Cooley Pediatric Clamp, delicate clamp, jaws calibrated at 5.0 mm intervals, 5-1/2" (14.0 cm), satinsky
NOVO SURGICAL, INC.
5550-03
Not in Commercial Distribution

  • 00842331115776 ()

  • Length: 14 Centimeter
5550-03

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Bishop-Harmon Cannula, 19 Gauge, Angled 30° at 5mm from bend to spatulated tip, 25mm tip length
Diamatrix
C191
In Commercial Distribution

  • 00813059017055 ()
C191

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Albumin Reagent Set for the quantitative determination of Albumin in serum. Packaged at 14 x 100ml
POINTE SCIENTIFIC, INC.
HA901-1400
In Commercial Distribution

  • 00811727012524 ()
HA901-1400

  • Albumin IVD, kit, spectrophotometry
BODYMED LED MOIST AND DRY HEATING PAD, WITH AUTO SHUT-OFF AT 2 HOURS. 12" X 15"
BOXOUT, LLC
ZZHP1215EA
In Commercial Distribution

  • 20815991024195 ()
  • 00815991024191 ()


  • External electric-heating core temperature regulation system pad
Bishop-Harmon Cannula, 19 Gauge, Angled 35° at 7mm from bend to spatulated tip, 24mm tip length
Diamatrix
C190-19
In Commercial Distribution

  • 00813059014962 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
OptiFix AT Absorbable Fixation System with Articulating Technology, 37 cm length, 5 mm diameter, 30 Fasteners
Davol Inc.
0113330
In Commercial Distribution

  • 10801741136563 ()
  • 00801741136566 ()

  • Length: 37 Centimeter
  • Outer Diameter: 5 Millimeter
0113330

  • Soft-tissue/mesh anchor, bioabsorbable
OptiFix AT Absorbable Fixation System with Articulating Technology, 37 cm length, 5 mm diameter, 15 Fasteners
Davol Inc.
0113315
In Commercial Distribution

  • 10801741136556 ()
  • 00801741136559 ()

  • Length: 37 Centimeter
  • Outer Diameter: 5 Millimeter
0113315

  • Soft-tissue/mesh anchor, bioabsorbable
The Fenestration Punch is used for making small fenestrations in a Provox LaryTube at desired locations.
Atos Medical AB
7654
Not in Commercial Distribution

  • 07331791002632 ()
7654

  • Tracheostomy tube, non-reinforced, non-customized, reusable
Grene Visual Axis Marker, 1.5mm Bend At Tip, Smooth Flat Handle, Overall Length 4-1/2" (115mm)
Med Saver, Inc.
11-4-9212
In Commercial Distribution

  • 00194613042073 ()


  • Corneal marker, reusable
RENASYS EDGE Carry Bag
SMITH & NEPHEW MEDICAL LIMITED
66803136
In Commercial Distribution

  • 05000223501136 ()
  • 05000223501129 ()

  • 172x135 x134W x H x Dmm (approximate dimensions with strap at longest)
66803136

  • Negative-pressure wound therapy system, electric, reusable
Crestpoint Mr. Phaco Mackool Maxicurve Big Ball Chopper (horizontal) DBL-Ended 0.6mm Mackool ball shaped tip with C-shaped curved shaft, Angled 10mm at 45* / Cylindrical Spatula, slightly vaulted 11.5mm at 50*, short round knurled handle, Stainless Steel
Crestpoint Management Limited
PH6004
In Commercial Distribution

  • G412PH60040 ()


  • Soft-tissue surgical hook, 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
A comprehensive at home fertility test that measures four key hormones that impact your cycle and fertility.
Mfb Fertility, Inc.
Complete
In Commercial Distribution

  • 00850035206065 ()


  • Natural conception assistance kit
Portable, battery powered laser therapy device emitting up to 3W at 808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30 MaxIR
In Commercial Distribution

  • 00852116008209 ()


  • Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 2W at 635nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30 MaxR
In Commercial Distribution

  • 00852116008193 ()


  • Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 3W at 808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-ProIR
Not in Commercial Distribution

  • 00852116008049 ()


  • Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 2W at 635nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-ProR
Not in Commercial Distribution

  • 00852116008032 ()


  • Musculoskeletal/physical therapy laser, professional
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
Integra® Miltex® Gill-Hess Iris Forceps, 2-7/8", 1 x 2 Teeth, 0.5mm Wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-830
In Commercial Distribution

  • H834188300 ()
  • 10381780418115 ()

  • Width: 0.5 Millimeter
  • 2-7/8"
18-830

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Integra® Miltex® Eye Dressing Forceps 3-7/8", Standard, Full Curved, Serrated, 0.8mm wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-784
In Commercial Distribution

  • H834187840 ()
  • 10381780417873 ()
18-784

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Integra® Jarit® Gill-Hess Iris Forceps 2-7/8", 1 x 2 Teeth, 0.5mm Wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
X29941
In Commercial Distribution

  • M274X299411 ()
  • 10381780406143 ()
X29941

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Troutman-Barraquer colibri corneal forceps, 2 7/8'', 0.12mm 1x2 teeth set at 45 degrees, flat handle, titanium
AMBLER SURGICAL CORP.
Troutman-Barraquer colibri corneal forceps
In Commercial Distribution

  • 00190660076108 ()
2240T

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Frontal ostium seeker, 7 5/8'', double-ended, curved, ball tips, one end at 90 degrees, hexagonal handle
AMBLER SURGICAL CORP.
Frontal ostium seeker
In Commercial Distribution

  • 00190660110246 ()
44-945

  • Fistula probe
Mendez Degree Gauge, Small Size, 12mm/14mm with 4 slots at 0, 90, 180 and 270 Degrees
AURORA SURGICAL, LLC
AS2-0071T
In Commercial Distribution

  • 08175700106733 ()
AS2-0071T

  • Medical ruler, 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
Colibri Corneal Utility Forceps Very Delicate 1x2 Teeth set at 90 Degree, .12mm, 73mm Overall Length, Titanium
Crestpoint Management Limited
PH1027T
In Commercial Distribution

  • G412PH1027T0 ()


  • Ophthalmic surgical device handling forceps, reusable
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
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 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 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
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
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
Liquid Urine Control - Level 2, 25 ml. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
323-17-2
In Commercial Distribution

  • 30858512007120 ()
  • 10858512007126 ()

  • Total Volume: 25 Milliliter
323-17-2

  • Multiple urine analyte IVD, control
Liquid Urine Control - Level 1, 25 ml. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
323-17-1
In Commercial Distribution

  • 30858512007113 ()
  • 10858512007119 ()

  • Total Volume: 25 Milliliter
323-17-1

  • Multiple urine analyte IVD, control
Liquid Urine Control - Level 2, 10 ml. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
323-16-2
In Commercial Distribution

  • 30858512007090 ()
  • 10858512007096 ()

  • Total Volume: 10 Milliliter
323-16-2

  • Multiple urine analyte IVD, control
Liquid Urine Control - Level 1, 10 ml. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
323-16-1
In Commercial Distribution

  • 30858512007083 ()
  • 10858512007089 ()

  • Total Volume: 10 Milliliter
323-16-1

  • Multiple urine analyte IVD, control
NORTHBENT Ligature Scissors, curved to side, 4 3/4", (120 mm), notch at the tip, non-sterile, reusable
Aesculap AG
BC805R
In Commercial Distribution

  • 04038653138524 ()
BC805R

  • General-purpose surgical scissors, reusable
Dental Suction Tip, 5 1/2", (140 mm), diam. 2 mm, notch at the tip, non-sterile, reusable
Aesculap AG
DF771R
In Commercial Distribution

  • 04038653224807 ()
DF771R

  • Surgical/emergency suction cannula, non-illuminating, reusable
Retractor Blade, 5 teeth at 60° angle, 1" wide, c-shaped with post adapter, special made (Omni Style)
Avalign Technologies, Inc.
72-SM181123
In Commercial Distribution

  • 00190776384432 ()


  • Hand-held surgical retractor, 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
Elvarex 1/Mid Thigh High/Slant-Closed Toe/Thigh high without volant to sew at body bandage/Grey
BSN-Jobst GmbH
77309-00366-00
In Commercial Distribution

  • 04019702381672 ()

  • Pressure: 18-21 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 3/Thigh high without foot/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
79445-00006-00
In Commercial Distribution

  • 04019702281668 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Thigh high without foot/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
79447-00006-00
In Commercial Distribution

  • 04019702281606 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 1/Thigh high without foot/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
79446-00006-00
In Commercial Distribution

  • 04019702281026 ()

  • Pressure: 18-21 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Thigh high without foot/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
79444-00006-00
In Commercial Distribution

  • 04019702279962 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 4/Thigh high without foot/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
79498-00000-00
In Commercial Distribution

  • 04019702278842 ()

  • Pressure: >49 mmHg


  • Compression/pressure sock/stocking, reusable
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