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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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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
Promax Surgical Gown, 100% Polyester, Twill Tape Closure at Waist, Woven QCM, AAMI Level 4, Size XXL
STANDARD TEXTILE CO., INC.
75675213
In Commercial Distribution

  • 10634916825388 ()
  • 00634916825381 ()


  • Surgical gown, reusable
Promax Surgical Gown, 100% Polyester, Twill Tape Closure at Waist, Woven QCM, AAMI Level 4, Size X-Large
STANDARD TEXTILE CO., INC.
75675214
In Commercial Distribution

  • 10634916825371 ()
  • 00634916825374 ()


  • Surgical gown, reusable
Promax Surgical Gown, 100% Polyester, Twill Tape Closure at Waist, Woven QCM, AAMI Level 4, Size Large
STANDARD TEXTILE CO., INC.
75675215
In Commercial Distribution

  • 10634916825364 ()
  • 00634916825367 ()


  • Surgical gown, reusable
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
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
CATHETER GUIDE, STAINLESS STEEL, AUTOCLAVABLE, 4.75MM ROUND (.1870"), KNURLED HANDLE/STOP, 90 DEGREE BEND AT DISTAL END.
ELMED INCORPORATED
ST13CG0823
In Commercial Distribution

  • 00842180191426 ()
ST13CG0823

  • Robotic surgical system application software
5mm, 45cm, Suction Tube, Regular Tip Vented, Stainless Steel, Special Hub w/ Specs on File at Elmed
ELMED INCORPORATED
52945-411
In Commercial Distribution

  • 00842180182073 ()
52945-411

  • Laparoscopic surgical procedure kit, non-medicated, reusable
"Multi-hole suction tubes, Five holes at tip. 5Fr. Working length 6-1/2in (16.5cm), M= PARTIALLY CLOSED TIP"
ELMED INCORPORATED
36-9153M
In Commercial Distribution

  • 00842180199606 ()
36-9153M

  • ENT surgical procedure kit, non-medicated, reusable
CATHETER GUIDE, STAINLESS STEEL, AUTOCLAVABLE, 4.75MM ROUND (.1870"), KNURLED HANDLE/STOP, 90 DEGREE BEND AT DISTAL END.
ELMED INCORPORATED
13-CG0823
In Commercial Distribution

  • 00842180177390 ()
13-CG0823

  • Robotic surgical system application software
Frontal sinus probe, Double ended, angled hoot at one tip, 1.2 & 2 mm 8-1/2” (22 cm)
ELMED INCORPORATED
36382-41
In Commercial Distribution

  • 00842180175709 ()
36382-41

  • Surgical soft-tissue manipulation forceps, alligator, reusable
Cooley Anastomosis Clamp, jaws calibrated at 5.0 mm intervals, 6-1/2" (16.5 cm), 7.0 mm jaw depth
NOVO SURGICAL, INC.
C6671-22
In Commercial Distribution

  • 00842331124433 ()

  • Length: 16.5 Centimeter


  • Surgical A/V-shaped microvessel clamp
Cooley Anastomosis Clamp, jaws calibrated at 5.0 mm intervals, 6-1/2" (16.5 cm), 7.0 mm jaw depth
NOVO SURGICAL, INC.
5560-11
Not in Commercial Distribution

  • 00842331116957 ()

  • Length: 16.5 Centimeter
5560-11

  • Surgical A/V-shaped microvessel clamp
Cooley Miniature Multi Purpose Clamp, jaws calibrated at 5.0 mm intervals, 60 degree angle, 6" (15.2 cm)
NOVO SURGICAL, INC.
5550-18
Not in Commercial Distribution

  • 00842331116339 ()

  • Length: 15.2 Centimeter
5550-18

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
kleegman dilator, double-ended, stainless steel, 1.8 mm to 2.5 mm at tips, 10 3/4" (27.0 cm)
NOVO SURGICAL, INC.
OB6348-14
In Commercial Distribution

  • 00842331149832 ()
OB6348-14

  • Vaginal dilator
Cooley Miniature Multi Purpose Clamp, jaws calibrated at 5.0 mm intervals, 60 degree angle, 6" (15.2 cm)
NOVO SURGICAL, INC.
C6661-29
In Commercial Distribution

  • 00842331123818 ()

  • Length: 15.2 Centimeter


  • Surgical A/V-shaped microvessel clamp
Brun (Spratt) Curette With Hollow Handle Oval Cup Size 2 Angled At 45° Overall Length 9"" (229mm)
Med Saver, Inc.
D9114
In Commercial Distribution

  • 00194613112264 ()


  • Bone curette, reusable
Brun (Spratt) Curette With Hollow Handle Oval Cup Size 0 Angled At 45° Overall Length 9"" (229mm)
Med Saver, Inc.
D9112
In Commercial Distribution

  • 00194613111991 ()


  • Bone curette, reusable
Multi-hole suction tubes, Five holes at tip. 7Fr. Working length 4-1/2in (11.4cm). M= PARTIALLY CLOSED TIP
ELMED INCORPORATED
36-9152M
In Commercial Distribution

  • 00198506074653 ()
36-9152M

  • ENT surgical procedure kit, non-medicated, reusable
Multi-hole suction tubes, Five holes at tip. 5Fr. Working length 4-1/2in (11.4cm). M= PARTIALLY CLOSED TIP
ELMED INCORPORATED
36-9151M
In Commercial Distribution

  • 00198506074646 ()
36-9151M

  • ENT surgical procedure kit, non-medicated, reusable
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
Prism Set, Viewing, 3 Sizes, fits Flanged Macintosh Blades, Sizes 2, 3, & 4, 30° Refraction at Tip
ANESTHESIA ASSOCIATES, INC.
00-349-5
In Commercial Distribution

  • B0050034950 ()
00-349-5

  • Rigid intubation laryngoscope, 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
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
Zone Air Nylon 6 x 35.5 x 84 Cover Kit (tube at foot) W/Cov, Liner, Foam
CASCO MANUFACTURING SOLUTIONS, INC.
H10342
In Commercial Distribution

  • 00815073021605 ()
H10342

  • Waterproof bed mattress cover, reusable
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