Gyrus ACMI

GUDID 00821925025011

SHEEHY-TYPE COLLAR BUTTON TWIN PACK SIXTY FLUOROPLASTIC 1.27 MM ID (60/PK)

Gyrus Acmi, Inc.

Tympanostomy tube
Primary Device ID00821925025011
NIH Device Record Keyeb69cbac-33da-4c56-b8cb-66c95e36f837
Commercial Distribution StatusIn Commercial Distribution
Brand NameGyrus ACMI
Version Model Number70145771
Company DUNS007198742
Company NameGyrus Acmi, Inc.
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100821925025011 [Package]
Contains: 00821925032552
Package: [60 Units]
In Commercial Distribution
GS100821925032552 [Primary]
GS180821925032558 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETDTube, Tympanostomy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-01
Device Publish Date2024-07-24

On-Brand Devices [Gyrus ACMI]

00821925038356Ellik Tubing For Ellik/Toomey Adapters
00821925015708SCHUKNECHT CRESCENT FLUOROPLASTIC
00821925044630DURAVENT VENTILATION TUBE WITH TWIN SPOON FLANGES 1.27 MM I.D. BLUE SILICONE TAPERED LUMEN
00821925028913Single Incision Inner Tube Assembly
80821925032435DURAVENT VENTILATION TUBE WITH TWIN SPOON FLANGES 1.27 MM I.D. BLUE SILICONE TAPERED LUMEN TWIN
00821925008779Cleaning Brush 5 Fr, 60 cm
00821925005037Cystoscopic Electrode With Interchangeable Tips 8 Fr, (2.7 mm) 37 cm
00821925004870Ballenger Follicle Electrode 6 Fr, (2 mm) 37 cm, Color Coded Green
00821925004801Fulgurating Electrode, Domed Tip 8 Fr, (2.7 mm) 37 cm, Color Coded Blue
00821925004795Fulgurating Electrode, Domed Tip 6 Fr, (2 mm) 37 cm, Color Coded Green
00821925004634McCarthy Fulgurating Electrode 8 Fr, (2.7 mm) 37 cm, Color Coded Blue
00821925004290Fulgurating Electrode, Ball Tip 8 Fr, (2.7 mm) 37 cm, Color Coded Blue
00821925004283Fulgurating Electrode, Ball Tip 6 Fr, (2 mm) 37 cm, Color Coded Green
00821925003866Fulgurating Electrode, Conical Tip 8 Fr, (2.7 mm) 37 cm, Color Coded Blue
00821925003859Fulgurating Electrode, Conical Tip 6 Fr, (2 mm) 37 cm, Color Coded Green
00821925025035SHEEHY COLLAR BUTTON PACIFIC 1.27 MM FLUOROPLASTIC VENTILATION TUBES TWIN PACK (60/PK)
00821925018341REUTER-BOBBIN VENT TUBE 1.00 MM I.D. 1.00 MM INTERFLANGE STAINLESS TWIN PACK (60/PK)
00821925026896PAPARELLA-TYPE VENT TUBE 1.27 MM ID SILICONE TWIN PACK (60/PK)
00821925017955DONALDSON VENT WITH TAB 1.14 MM I.D. SILICONE TWIN PACK (60/Pk)
80821925032794STRAIGHT VENT TUBE 0.89 MM I.D. 7 MM LENGTH FLUOROPLASTIC, TWIN PACK (60/PK)
00821925017931RICHARDS MODIFIED T-TUBE 1.32 MM I.D. 4.8 MM LENGTH SILICONE TWIN PACK (60/PK)
00821925026605ARMSTRONG VENT TUBE W/TAB 1.14MM ID ULTRASIL SILICONE TWIN PACK (60/PK)
00821925026216PAPARELLA-TYPE VENT TUBE 1.14 MM I.D. ULTRASIL SILICONE TWIN PACK (60/PK)
00821925018037MICRON BOBBIN VENT TUBE TWIN PACK 1.27 MM I.D. TITANIUM
00821925024786POPE BEVELED GROMMET 1.14 MM ID BLUE POLYETHYLENE TWIN PACK (60/PK)
00821925032675SHEPARD GROMMET VENT TUBE W/O WIRE TAB 1.0 MM I.D. FLUOROPLASTIC, TWIN PACK (60/PK)
00821925017948RICHARDS T-TUBE 1.14 MM I.D. 12 MM LENGTH SILICONE TWIN PACK (60/PK)
00821925026957ULTRASIL SHEEHY TYPE COLLAR BUTTON 1.27 MM ID ULTRASIL SILICONE TWIN PACK (60/PK)
00821925020214ARMSTRONG V TYPE GROMMET BLUE 1.14 MM ID FLUOROPLASTIC PACIFIC TWIN PACK (60/PK)
00821925026636SHEEHY TYPE COLAR BUTTON 1.27 MM ID SILICONE TWIN PACK (60/PK)
00821925017924SHEA PARASOL VENT TUBE 1.02 MM I.D. SILICONE, TWIN PACK (60/PK)
00821925025011SHEEHY-TYPE COLLAR BUTTON TWIN PACK SIXTY FLUOROPLASTIC 1.27 MM ID (60/PK)
00821925019751PAPARELLA VENT TUBE 1.02 MM I.D. SILICONE, TWIN PACK (60/PK)
00821925018112COLLAR BUTTON VENT TUBE 1.27 MM I.D. FLUOROPLASTIC, TWIN PACK (60/PK)
00821925027039COLLAR BUTTON VENT TUBE 1.27 MM ID ULTRASIL SILICONE VENTILATION TUBES TWIN PACK (60/PK)
00821925026513DURAVENT VENTILATION TUBE WITH TWIN FLANGES 1.27 MM ID UNTRASIL SILICONE TAPERED LUMEN
00821925031883DURAVENT VENTILATION TUBE TAPERED LUMEN WITH SPOON FLANGES 1.27 MM I.D. BLUE SILICONE
00821925010567BiPolar Connector Cable with Banana Pins
00821925008960Flexible Scissors 5 Fr (1.67mm), 58 CM
00821925008045Universal Active Cord Adapter For Use With DAC/GDAC And ValleyLab Or Bovie Electrosurgical Units
00821925007512SMALL REPLACEMENT HANDLE AND KNOB ASSEMBLY
00821925007505Large Replacement Handle And Knob Assembly
00821925007499Flexible Rat Tooth Grasping Forceps 3 Fr (1mm), 60 CM
00821925006256Semi-Rigid Endourology Alligator Forceps 5 Fr (1.67mm), 65 CM
00821925003798Flexible Alligator Forceps 5 Fr (1.67mm), 58 CM
00821925000926"O" RINGS FOR GAUZE SAC
00821925010819j PlasmaKnife 5 mm, 15 cm (5/PK)
00821925022379EPISTAXIS BALOON CATHETER KIT. CONTAINS: ONE CATHETER, ONE 10 CC SYRINGE AND TWO 4 x 4". GAUZE P
0082192501093210FR (3.3mm) DUAL LUMEN CATHETER
00821925037441Biopsy 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
GYRUS ACMI
78845492 3410751 Live/Registered
GYRUS ACMI, INC.
2006-03-24

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