Curved Lowsley™ Tractor Single-Action, Stem Only 21.5 Fr (7.1mm) With

GUDID 00821925005082

"437 Lowsley Tractor Curved 10.5 Inch"

Gyrus Acmi, Inc.

Gastro-urological hook Gastro-urological hook Suprapubic catheter introducer Suprapubic catheter introducer Suprapubic catheter introducer Suprapubic catheter introducer Suprapubic catheter introducer Suprapubic catheter introducer Suprapubic catheter introducer Suprapubic catheter introducer Suprapubic catheter introducer Suprapubic catheter introducer Suprapubic catheter introducer Suprapubic catheter introducer Suprapubic catheter introducer Suprapubic catheter introducer Suprapubic catheter introducer Suprapubic catheter introducer Suprapubic catheter introducer Suprapubic catheter introducer, reusable Suprapubic catheter introducer, reusable Suprapubic catheter introducer, reusable Suprapubic catheter introducer, reusable Suprapubic catheter introducer, reusable Suprapubic catheter introducer, reusable Suprapubic catheter introducer, reusable Suprapubic catheter introducer, reusable Suprapubic catheter introducer, reusable Suprapubic catheter introducer, reusable Suprapubic catheter introducer, reusable Suprapubic catheter introducer, reusable Suprapubic catheter introducer, reusable Suprapubic catheter introducer, reusable Suprapubic catheter introducer, reusable Suprapubic catheter introducer, reusable Suprapubic catheter introducer, reusable

• Primary Device ID: 00821925005082
• NIH Device Record Key: ff0945d2-f4dc-4540-b063-48aa081359fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Curved Lowsley™ Tractor Single-Action, Stem Only 21.5 Fr (7.1mm) With
• Version Model Number: 437
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925005082 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012153

FDA Product Code

• KOB: CATHETER, SUPRAPUBIC (AND ACCESSORIES)

Sterilization

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

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

[00821925005082]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-12

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• 00810008180501 - nCare: 2023-09-25 nCare, Sgl,Direct SDI,DICOM,Rcrdg
• 00810008180921 - nCare: 2023-09-25 nCare, Dual,ELA x 2,DICOM,Rcrdg
• 00810008180952 - nCare: 2023-09-25 nCare, SNGL,DRCT SDI,DICOM
• 00810008180969 - nCare: 2023-09-25 nCare, SNGL, ELA, DICOM
• 00810008180976 - nCare: 2023-09-25 nCare, SNGL, ELA, DICOM, RCRDG
• 00821925036406 - USA Elite: 2023-07-26 ACMI USA Elite System and USA Series Knife Electrode 24 Fr (8mm)