Gyrus ACMI
GUDID 00821925010819
j PlasmaKnife 5 mm, 15 cm (5/PK)
Gyrus Acmi, Inc.
Electrosurgical system| Primary Device ID | 00821925010819 |
| NIH Device Record Key | 6d20b483-45a4-403b-a214-6bd5b3474f54 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gyrus ACMI |
| Version Model Number | 7035-3006 |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821925010819 [Package] Contains: 00821925042551 Package: [5 Units] In Commercial Distribution |
| GS1 | 00821925042551 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K050460
FDA Product Code
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
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) |
Trademark Results [Gyrus ACMI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GYRUS ACMI 78845492 3410751 Live/Registered |
GYRUS ACMI, INC. 2006-03-24 |
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