Avalign

GUDID 00190776134969

Langenbeck Retractor, #1, 3/8" X 1 1/4"

AVALIGN TECHNOLOGIES, INC.

Self-retaining surgical retractor, reusable

• Primary Device ID: 00190776134969
• NIH Device Record Key: c075fb75-aa52-4553-8ee9-904f330c8ebf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avalign
• Version Model Number: VM84-2175
• 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	00190776134969 [Primary]

FDA Product Code

• GZT: Retractor, Self-Retaining, For Neurosurgery

Sterilization

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

[00190776134969]

Moist Heat or Steam Sterilization

[00190776134969]

Moist Heat or Steam Sterilization

[00190776134969]

Moist Heat or Steam Sterilization

[00190776134969]

Moist Heat or Steam Sterilization

[00190776134969]

Moist Heat or Steam Sterilization

[00190776134969]

Moist Heat or Steam Sterilization

[00190776134969]

Moist Heat or Steam Sterilization

[00190776134969]

Moist Heat or Steam Sterilization

[00190776134969]

Moist Heat or Steam Sterilization

[00190776134969]

Moist Heat or Steam Sterilization

[00190776134969]

Moist Heat or Steam Sterilization

[00190776134969]

Moist Heat or Steam Sterilization

[00190776134969]

Moist Heat or Steam Sterilization

[00190776134969]

Moist Heat or Steam Sterilization

[00190776134969]

Moist Heat or Steam Sterilization

[00190776134969]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-23
• Device Publish Date: 2018-10-23

On-Brand Devices [Avalign]

• 00190776139834: Malis Bipolar Forcep, Straight,Insulated, w/o Irrigation, Flat Handle, TW 1mm, OL 127mm (7 7/8")
• 00190776139810: Ducker Retractor,BL 60mm (2 1/4"), BW 20mm (3/4"),BW 6mm, OL 177mm (7")
• 00190776139803: Micro Kerrison, 9mm opening, Angled up 40 degrees,TW 5mm, SL180mm(7 1/8"),OL255mm(10"), Black &
• 00190776139735: Chroma-Line Suction Tube, Medium, Blue, 4fr, WL 120mm(4 3/4"), OL190mm(7 1/2")
• 00190776139728: Chroma-Line Suction Tube,Short, Navy, 10 fr, WL 90mm(3 1/2"), OL 146mm(5 3/4'')
• 00190776139711: Chroma-Line Suction Tube, Short, Black, 8fr, WL 90mm(3 1/2"), OL 146mm(5 3/4'')
• 00190776139704: Heaney Hysterectomy Retractor,75x29mm blade,OL 268mm (10 1/2")
• 00190776139629: Andrews Pynchon Suction Tube, No removeable pieces,TubeDiameter, 6.0mmWL95mm(3 3/4")OL240mm(9 1/
• 00190776139469: Esophogeal Retractor, Ø 5mm, WL 335mm, 1.5mm x, 2.5mm hole, flushable, OL 436mm(17 1/8")
• 00190776139452: Titanium Micro Clamp, str.shank, 6mm spoon jaw
• 00190776139353: Micro Kerr take-apart, 2mm, 40deg up, 7"
• 00190776136024: Ferris Smith Pituitary Rongeur,straight, JL 10mm, jaw width 4mm,WL 305mm (12")
• 00190776136000: Micro Kerrison, Angled up 40 degrees, 15mm Jaw Opening, TW 5mm (1/4"), SL 255mm (10"), OL 315mm
• 00190776135966: Yasargil Bipolar Forcep, Insulated, Irrigating, Bayonet, TW 0.5mm, OL 159mm (6 1/4")
• 00190776135959: Frazier Suction Tube with slot,angled, 12FR,WL 130mm (5"),OL 220mm (8 5/8")
• 00190776135904: Glenner Hysterectomy Forceps, Curved Left, OL 210mm (8 1/4")
• 00190776135898: Wide Jaw Micro Kerrison, 15mm opening, Angled up 40°,TW 2mm,WL200mm(7 7/8")OL260mm(10 1/4"), Bl
• 00190776135874: Wide Jaw Micro Kerrison, 40 Degree Up,TW 1.5 mm, SL 200 mm (8"), Black & Gold
• 00190776135867: Fan Retractor, straight,articulating shaft, shaft diameter 5mm, SL 335mm (13 1/8"), OL 475mm (18
• 00190776135843: Cooley Vascular Clamp, Angled 60 degrees, Small Jaw
• 00190776135836: Debakey Derra Anastomosis, Clamp, Small Jaw, TW 2.5mm, OL 165mm(6 1/2")
• 00190776135829: Gregory Profunda Clamp, Medium Jaw, JW 2.5mm, JH 46.0mm OL 180mm (7 1/8")
• 00190776135812: Gregory Profunda Clamp, Extra Small, JW 2.0mm, JH 32.0mm OL 120mm(4 3/4")
• 00190776135713: Bipolar Forcep, round handle, bayonet, insulated, irrigating, OL273mm(10 1/2") TW .5mm Titanium
• 00190776135614: Spurling IVD Rongeur, straight, with teeth, jaw width 4mm, jaw length 10mm, SL 255mm (10")
• 00190776135591: IVD Ronguer, straight,JL 10mm, jaw width 5mm,SL 300mm(11 3/4"), OL 370mm(14 5/8")
• 00190776135584: Duckbill Forceps, fenestrated, monopolar, single action, w/o ratchet, Insulated, Diameter 5mm, W
• 00190776135577: Chroma-Line Suction Tube, Short, Green, 6fr, WL 90mm(3 1/2"), OL 151mm(6")
• 00190776135560: Chroma-Line Suction Tube, Short, Blue, 4 fr, WL 90mm(3 1/2"), OL 146mm(5 3/4'')
• 00190776135508: Ferris Smith Pituitary Rongeur, Straight, JW 5mm, SL 305mm(12"), OL 372mm(14 5/8")
• 00190776135492: Laufe Divergent Outlet Forceps, OL 325mm (12 3/4")
• 00190776135478: Intervertebral Disc Rongeur, straight, JL 280.3mm, jaw width 4.8mm OL 349mm(13 3/4")
• 00190776135461: Intervertebral Disc Rongeur,curved down, JL 10mm, JW 6.0mm, WL 150mm (5 7/8")
• 00190776135409: Lateral Wall Retractor, BL 65mm, BW 23mm, OL 250mm (9 7/8")
• 00190776135348: Cohen Acorn Small Cone, Tube 3.24mm, TL 31.0mm, OL 60mm(2 3/8")
• 00190776135331: Cohen Acorn Large Cone, OL 60mm(2 3/8")
• 00190776135324: Jeweler Bipolar Forcep, OL 101.6mm (4 3/4"), TW .4mm
• 00190776135270: Cohen Acorn Cannula Intrauterine Probe, Spring-mount Forcep,Small and Large, Cones,Diameter 3.5
• 00190776135263: Hulka Single Tooth Tenaculum, Forcep, 1 gold handle, Ratchet, Tip 3.5mm, OL 280mm(11 1/2")
• 00190776135188: Kay Lamb Aortic Anastomosis Clamp, Tip Height 47mm, TW 5mm, TL 50mm, OL 200mm(7 7/8")
• 00190776135171: Hemogrip Clamp, angled, OL 240mm(9 1/2")
• 00190776135164: Debakey Derra Anastomosis Clamp, Large jaw, TW 2.5mm, OL 175mm(6 7/8")
• 00190776135157: Poole Suction Tube, Straight, 30fr, TubeDiameter10.0mm, WL180mm(7 1/8")OL235mm(9 1/4")
• 00190776135140: Anterior Rongeur, double action,jaw width 5.3mm,OL 357mm (14")
• 00190776135102: Ferris Smith Pituitary Rongeur,angled down, jaw width 4mm, SL 255mm (10")
• 00190776135027: Zelpi Style Weitlaner Retractor, Depth 127mm (5"), BW 19mm, OL 305mm (12")
• 00190776135010: Debakey Aortic Aneurysm Clamp, 12cm, 2x3 teeth, 14"
• 00190776134976: Cloward Style Blade Retractor, w/o lip, BW 13mm, BL 77mm, OL 174mm (6 7/8")
• 00190776134969: Langenbeck Retractor, #1, 3/8" X 1 1/4"
• 00190776134952: Decker Rongeur, straight, CW 2mm, CL 5.5mm, SL 150mm(5 7/8"), OL 200mm(7 7/8")