Millennium

GUDID 00190776123024

Bayonet Bipolar Forceps

AVALIGN TECHNOLOGIES, INC.

Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

• Primary Device ID: 00190776123024
• NIH Device Record Key: d8a61ff3-3fd6-4722-85f2-1c46f70bc37a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Millennium
• Version Model Number: 85-000835
• Company DUNS: 792528510
• Company Name: AVALIGN TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)289-1096
• Email: product.questions@avalign.com
• Phone: +1(877)289-1096
• Email: product.questions@avalign.com
• Phone: +1(877)289-1096
• Email: product.questions@avalign.com
• Phone: +1(877)289-1096
• Email: product.questions@avalign.com
• Phone: +1(877)289-1096
• Email: product.questions@avalign.com
• Phone: +1(877)289-1096
• Email: product.questions@avalign.com
• Phone: +1(877)289-1096
• Email: product.questions@avalign.com
• Phone: +1(877)289-1096
• Email: product.questions@avalign.com
• Phone: +1(877)289-1096
• Email: product.questions@avalign.com
• Phone: +1(877)289-1096
• Email: product.questions@avalign.com
• Phone: +1(877)289-1096
• Email: product.questions@avalign.com
• Phone: +1(877)289-1096
• Email: product.questions@avalign.com
• Phone: +1(877)289-1096
• Email: product.questions@avalign.com
• Phone: +1(877)289-1096
• Email: product.questions@avalign.com
• Phone: +1(877)289-1096
• Email: product.questions@avalign.com
• Phone: +1(877)289-1096
• Email: product.questions@avalign.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190776123024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974593

FDA Product Code

• GEI: Electrosurgical, cutting & coagulation & accessories

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00190776123024]

Moist Heat or Steam Sterilization

[00190776123024]

Moist Heat or Steam Sterilization

[00190776123024]

Moist Heat or Steam Sterilization

[00190776123024]

Moist Heat or Steam Sterilization

[00190776123024]

Moist Heat or Steam Sterilization

[00190776123024]

Moist Heat or Steam Sterilization

[00190776123024]

Moist Heat or Steam Sterilization

[00190776123024]

Moist Heat or Steam Sterilization

[00190776123024]

Moist Heat or Steam Sterilization

[00190776123024]

Moist Heat or Steam Sterilization

[00190776123024]

Moist Heat or Steam Sterilization

[00190776123024]

Moist Heat or Steam Sterilization

[00190776123024]

Moist Heat or Steam Sterilization

[00190776123024]

Moist Heat or Steam Sterilization

[00190776123024]

Moist Heat or Steam Sterilization

[00190776123024]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-30

On-Brand Devices [Millennium]

• 00190776139841: Semkin Bipolar Forcep, OL 139.7mm, TW .75mm
• 00190776139797: Love Gruenwald IVD Rongeur,straight, Titanium
• 00190776139780: Frazier Suction Tube, 7Fr, TW 2mm, OL 295mm (11 5/8") Titanium
• 00190776139612: Malis Bipolar Irri., Fcp, Bayo, Ins, 8 3/4" titanium, circular loop tip, 10mm wide
• 00190776139506: Cushing IVD Rongeur, angled up,jaw width 2mm, SL 280mm (11")
• 00190776139490: Frazier Suction Tube, Angled, 9fr, WL 190mm, tube 230mm 9", 285mm overall 11.4", round hole
• 00190776139483: Ferris Smith IVD Rongeur,straight, with teeth, JW 5mm, JL 10mm, SL 180mm(7 1/8")
• 00190776139476: Cloward Style Vertebra Spreader, #1, Jaw 25.5mm, Open 18mm, TW 3mm (1/8"), OL 110mm (4 3/8")
• 00190776139421: Keyhole Bracket, hole opening 4mm (.157"), silicone, height 25.4mm (1"), OL 38.1mm (1.5")
• 00190776139414: Sella Punch, 40 Degree Down, TW 1mm, WL 200 mm (8")
• 00190776139407: Micro Kerrison, 40 Degree Down, TW 2 mm, WL 200 mm (8")
• 00190776139391: Micro Kerrison, 40 Degree Down,TW 4 mm, OL 205 mm (8")
• 00190776139384: Right Angle Electrode, With Suction, WL 330mm (13")
• 00190776139377: Ultra Bulldog Artery Clamp, Atraumatic teeth, curved, OL 50.0mm, Titanium
• 00190776139339: Chroma-Line Suction Tube, Medium, Red, 5fr, WL 120mm(4 3/4"), OL190mm(7 1/2")
• 00190776139322: Chroma-Line Suction Tube, Medium, Gold, 9fr, WL 120mm(4 3/4"), OL 190mm(7 1/2")
• 00190776136062: Ferris Smith IVD Rongeur, straight,without teeth, jaw width 4mm, SL 230mm (9"), OL 300mm (11 7/8
• 00190776136055: Ejector Rongeur, 40° up, TW 3mm,WL 305mm (12"), OL 375mm (14 3/4")
• 00190776136017: Z-Clamp Straight Handles, slight curv., 16"
• 00190776135997: Zelpi Style Weitlaner Retractor, 83mm (3 1/4") deep, OL 260mm (10 1/4")
• 00190776135980: Micro Kerrison Shaft Only, Rotatable, 40 Degree Up,TW 3 mm, SL 203 mm (8")
• 00190776135973: Lane Bone Forceps, Ratchet, TW 13mm, OL 430mm(16 7/8")
• 00190776135942: Pituitary Rongeur, with micro teething,straight, TW 5mm, SL 200mm (8"),OL 270mm (10 5/8")
• 00190776135935: Pituitary Rongeur, with micro teething,up bite, CW 3mm, SL 200mm (8"),OL 270mm (10 5/8")
• 00190776135928: Pituitary Rongeur, with micro teething,up bite, TW 5mm, SL 200mm (8"),OL 270mm (10 5/8")
• 00190776135881: McPherson Bipolar Forcep, platform, OL 88.9mm (3"), , TW .5mm
• 00190776135737: Spinal Discectomy Retractor, prong left, OL 170mm (6 5/8") BL 120mm x BW 20mm
• 00190776135706: Spinal Discectomy Retractor, prong right, OL 175mm (6 3/4") BL 120mm x BW 20mm
• 00190776135683: Micro Kerrison, 40 Degree Up, TL 214 mm, TW 1.63 mm, OL 272 mm (11"), Black & Gol
• 00190776135669: Glover Bulldog Clamp, Debakey jaws, straight jaws, with adjusting screw to, regulate tension, OL
• 00190776135621: Zelpi Retractor, 90 degree angle, 4" deep, OL 250mm (9 7/8") 100mm (4") deep prongs
• 00190776135607: Strong Grasping Forcep, Fenestrated, Insulated,Port,Double Action,Diameter5mm, WL 350mm(13 3/4")
• 00190776135553: Cushing IVD Rongeur, straight, JL 10mm, jaw width 2mm, WL 255mm (10"), OL 325mm(12 3/4")
• 00190776135539: Ferris Smith Rongeur, with teeth, jaw width 5mm, SL 303mm (11 7/8"), OL 367mm (14 1/2")
• 00190776135485: Approximator Clamp w/frame, black, vein/artery size, 1.0mm-2.25mm
• 00190776135430: Fourth blade extension, left arm assembly without blade
• 00190776135393: Irrigating Aspirating Needle,12g, Shaft Diameter 5mm, SL 301mm(11 7/8"), OL 334mm(13 1/8")
• 00190776135362: Senning Bulldog Clamp #3, Medium, Light, TW 2.0mm OL 44mm(1 3/4")
• 00190776135355: Smith Peterson Sterilizing, Rack, holds 7 instruments
• 00190776135317: Z-Clamp, Angled Jaw, Straight Handle, TW 5mm, OL 350mm(13 3/4")
• 00190776135300: Z-Clamp, Angled Jaw, Straight Handle, TW 5.5mm, BL 58mm, OL 358mm(14 1/8")
• 00190776135294: Z-Clamp, Straight Jaw, Straight Handle, OL 367mm(14 1/2")
• 00190776135249: McKesson Aspirator Tip, Tube Diameter 3.0mm, OL180mm(7 1/8")
• 00190776135225: Articulating Triangular Retractor, flexible, shaft diameter 5mm, 60 mm working end, SL 340mm
• 00190776135218: Sella Punch, 90 degrees up, Bite 1mm, OL 297mm (11 3/4")
• 00190776135195: Pin Mat, silicone width 333.5mm (13.13"), OL 463.5mm (18 1/4"), Silicone
• 00190776135133: Fan Retractor, 5 fingers, Articulating, w/ port,WL 335mm (13 1/8"), spread 55mm
• 00190776135126: Leksell Rongeur, curved, jaw width 3mm, OL 230mm (9")
• 00190776135096: Hopkins Aorta Clamp, Angled 45degree, TW 2.5mm, JL 70.0mm OL 240mm(9 1/2")
• 00190776135089: Gillespie Obstetrical Forceps, Mirror Finish,OL 380mm(15")