Gyrus ACMI

GUDID 00821925035478

Trapeze Ribbon Loop 4.0 mm Length Platinum

Gyrus Acmi, Inc.

Ossicular prosthesis, partial

• Primary Device ID: 00821925035478
• NIH Device Record Key: 2fbee8e5-c238-46ac-b6b8-d57c79a1f7c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gyrus ACMI
• Version Model Number: 140741
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925035478 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K760434

FDA Product Code

• ETB: Prosthesis, Partial Ossicular Replacement

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-02
• Device Publish Date: 2024-07-25

On-Brand Devices [Gyrus ACMI]

• 00821925038356: Ellik Tubing For Ellik/Toomey Adapters
• 00821925015708: SCHUKNECHT CRESCENT FLUOROPLASTIC
• 00821925044630: DURAVENT VENTILATION TUBE WITH TWIN SPOON FLANGES 1.27 MM I.D. BLUE SILICONE TAPERED LUMEN
• 00821925028913: Single Incision Inner Tube Assembly
• 80821925032435: DURAVENT VENTILATION TUBE WITH TWIN SPOON FLANGES 1.27 MM I.D. BLUE SILICONE TAPERED LUMEN TWIN
• 00821925008779: Cleaning Brush 5 Fr, 60 cm
• 00821925005037: Cystoscopic Electrode With Interchangeable Tips 8 Fr, (2.7 mm) 37 cm
• 00821925004870: Ballenger Follicle Electrode 6 Fr, (2 mm) 37 cm, Color Coded Green
• 00821925004801: Fulgurating Electrode, Domed Tip 8 Fr, (2.7 mm) 37 cm, Color Coded Blue
• 00821925004795: Fulgurating Electrode, Domed Tip 6 Fr, (2 mm) 37 cm, Color Coded Green
• 00821925004634: McCarthy Fulgurating Electrode 8 Fr, (2.7 mm) 37 cm, Color Coded Blue
• 00821925004290: Fulgurating Electrode, Ball Tip 8 Fr, (2.7 mm) 37 cm, Color Coded Blue
• 00821925004283: Fulgurating Electrode, Ball Tip 6 Fr, (2 mm) 37 cm, Color Coded Green
• 00821925003866: Fulgurating Electrode, Conical Tip 8 Fr, (2.7 mm) 37 cm, Color Coded Blue
• 00821925003859: Fulgurating Electrode, Conical Tip 6 Fr, (2 mm) 37 cm, Color Coded Green
• 00821925025035: SHEEHY COLLAR BUTTON PACIFIC 1.27 MM FLUOROPLASTIC VENTILATION TUBES TWIN PACK (60/PK)
• 00821925018341: REUTER-BOBBIN VENT TUBE 1.00 MM I.D. 1.00 MM INTERFLANGE STAINLESS TWIN PACK (60/PK)
• 00821925026896: PAPARELLA-TYPE VENT TUBE 1.27 MM ID SILICONE TWIN PACK (60/PK)
• 00821925017955: DONALDSON VENT WITH TAB 1.14 MM I.D. SILICONE TWIN PACK (60/Pk)
• 80821925032794: STRAIGHT VENT TUBE 0.89 MM I.D. 7 MM LENGTH FLUOROPLASTIC, TWIN PACK (60/PK)
• 00821925017931: RICHARDS MODIFIED T-TUBE 1.32 MM I.D. 4.8 MM LENGTH SILICONE TWIN PACK (60/PK)
• 00821925026605: ARMSTRONG VENT TUBE W/TAB 1.14MM ID ULTRASIL SILICONE TWIN PACK (60/PK)
• 00821925026216: PAPARELLA-TYPE VENT TUBE 1.14 MM I.D. ULTRASIL SILICONE TWIN PACK (60/PK)
• 00821925018037: MICRON BOBBIN VENT TUBE TWIN PACK 1.27 MM I.D. TITANIUM
• 00821925024786: POPE BEVELED GROMMET 1.14 MM ID BLUE POLYETHYLENE TWIN PACK (60/PK)
• 00821925032675: SHEPARD GROMMET VENT TUBE W/O WIRE TAB 1.0 MM I.D. FLUOROPLASTIC, TWIN PACK (60/PK)
• 00821925017948: RICHARDS T-TUBE 1.14 MM I.D. 12 MM LENGTH SILICONE TWIN PACK (60/PK)
• 00821925026957: ULTRASIL SHEEHY TYPE COLLAR BUTTON 1.27 MM ID ULTRASIL SILICONE TWIN PACK (60/PK)
• 00821925020214: ARMSTRONG V TYPE GROMMET BLUE 1.14 MM ID FLUOROPLASTIC PACIFIC TWIN PACK (60/PK)
• 00821925026636: SHEEHY TYPE COLAR BUTTON 1.27 MM ID SILICONE TWIN PACK (60/PK)
• 00821925017924: SHEA PARASOL VENT TUBE 1.02 MM I.D. SILICONE, TWIN PACK (60/PK)
• 00821925025011: SHEEHY-TYPE COLLAR BUTTON TWIN PACK SIXTY FLUOROPLASTIC 1.27 MM ID (60/PK)
• 00821925019751: PAPARELLA VENT TUBE 1.02 MM I.D. SILICONE, TWIN PACK (60/PK)
• 00821925018112: COLLAR BUTTON VENT TUBE 1.27 MM I.D. FLUOROPLASTIC, TWIN PACK (60/PK)
• 00821925027039: COLLAR BUTTON VENT TUBE 1.27 MM ID ULTRASIL SILICONE VENTILATION TUBES TWIN PACK (60/PK)
• 00821925026513: DURAVENT VENTILATION TUBE WITH TWIN FLANGES 1.27 MM ID UNTRASIL SILICONE TAPERED LUMEN
• 00821925031883: DURAVENT VENTILATION TUBE TAPERED LUMEN WITH SPOON FLANGES 1.27 MM I.D. BLUE SILICONE
• 00821925010567: BiPolar Connector Cable with Banana Pins
• 00821925008960: Flexible Scissors 5 Fr (1.67mm), 58 CM
• 00821925008045: Universal Active Cord Adapter For Use With DAC/GDAC And ValleyLab Or Bovie Electrosurgical Units
• 00821925007512: SMALL REPLACEMENT HANDLE AND KNOB ASSEMBLY
• 00821925007505: Large Replacement Handle And Knob Assembly
• 00821925007499: Flexible Rat Tooth Grasping Forceps 3 Fr (1mm), 60 CM
• 00821925006256: Semi-Rigid Endourology Alligator Forceps 5 Fr (1.67mm), 65 CM
• 00821925003798: Flexible Alligator Forceps 5 Fr (1.67mm), 58 CM
• 00821925000926: "O" RINGS FOR GAUZE SAC
• 00821925010819: j PlasmaKnife 5 mm, 15 cm (5/PK)
• 00821925022379: EPISTAXIS BALOON CATHETER KIT. CONTAINS: ONE CATHETER, ONE 10 CC SYRINGE AND TWO 4 x 4". GAUZE P
• 00821925010932: 10FR (3.3mm) DUAL LUMEN CATHETER
• 00821925037441: Biopsy Portal Seal For Accessories up to 3 FR (1 mm) GS1-128 (6/PK)