Millennium
GUDID 00190776154042
GASTRIC BAND MANIPULATOR, 10MM, 36CM, ROTATABLE, RING HANDLE, WITH RATCHET
AVALIGN TECHNOLOGIES, INC.
Laparoscope system, reusable| Primary Device ID | 00190776154042 |
| NIH Device Record Key | 5e2b0727-ea53-4f08-bf91-b01568819aa6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Millennium |
| Version Model Number | 72-5251530B |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190776154042 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K181173
FDA Product Code
| GCJ | Laparoscope, General & Plastic Surgery |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190776154042]
Moist Heat or Steam Sterilization
[00190776154042]
Moist Heat or Steam Sterilization
[00190776154042]
Moist Heat or Steam Sterilization
[00190776154042]
Moist Heat or Steam Sterilization
[00190776154042]
Moist Heat or Steam Sterilization
[00190776154042]
Moist Heat or Steam Sterilization
[00190776154042]
Moist Heat or Steam Sterilization
[00190776154042]
Moist Heat or Steam Sterilization
[00190776154042]
Moist Heat or Steam Sterilization
[00190776154042]
Moist Heat or Steam Sterilization
[00190776154042]
Moist Heat or Steam Sterilization
[00190776154042]
Moist Heat or Steam Sterilization
[00190776154042]
Moist Heat or Steam Sterilization
[00190776154042]
Moist Heat or Steam Sterilization
[00190776154042]
Moist Heat or Steam Sterilization
[00190776154042]
Moist Heat or Steam Sterilization
[00190776154042]
Moist Heat or Steam Sterilization
[00190776154042]
Moist Heat or Steam Sterilization
[00190776154042]
Moist Heat or Steam Sterilization
[00190776154042]
Moist Heat or Steam Sterilization
[00190776154042]
Moist Heat or Steam Sterilization
[00190776154042]
Moist Heat or Steam Sterilization
[00190776154042]
Moist Heat or Steam Sterilization
[00190776154042]
Moist Heat or Steam Sterilization
[00190776154042]
Moist Heat or Steam Sterilization
[00190776154042]
Moist Heat or Steam Sterilization
[00190776154042]
Moist Heat or Steam Sterilization
[00190776154042]
Moist Heat or Steam Sterilization
[00190776154042]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-15 |
| Device Publish Date | 2020-07-07 |
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") |
Trademark Results [Millennium]
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