USA Elite System™ Rotating Continuous Flow Resectoscope Timberlake Ob

GUDID 00821925003149

ERTO-CF25 OBTURATOR TIMBER CF ROT 25FR

Gyrus Acmi, Inc.

Resectoscope

• Primary Device ID: 00821925003149
• NIH Device Record Key: 233832e9-3243-436c-90b6-e35c8af0f6a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: USA Elite System™ Rotating Continuous Flow Resectoscope Timberlake Ob
• Version Model Number: ERTO-CF25
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00821925003149 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K890328

FDA Product Code

• FEC: OBTURATOR, FOR ENDOSCOPE
• HIH: Hysteroscope (And Accessories)

Sterilization

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

[00821925003149]

Moist Heat or Steam Sterilization

[00821925003149]

Moist Heat or Steam Sterilization

[00821925003149]

Moist Heat or Steam Sterilization

[00821925003149]

Moist Heat or Steam Sterilization

[00821925003149]

Moist Heat or Steam Sterilization

[00821925003149]

Moist Heat or Steam Sterilization

[00821925003149]

Moist Heat or Steam Sterilization

[00821925003149]

Moist Heat or Steam Sterilization

[00821925003149]

Moist Heat or Steam Sterilization

[00821925003149]

Moist Heat or Steam Sterilization

[00821925003149]

Moist Heat or Steam Sterilization

[00821925003149]

Moist Heat or Steam Sterilization

[00821925003149]

Moist Heat or Steam Sterilization

[00821925003149]

Moist Heat or Steam Sterilization

[00821925003149]

Moist Heat or Steam Sterilization

[00821925003149]

Moist Heat or Steam Sterilization

[00821925003149]

Moist Heat or Steam Sterilization

[00821925003149]

Moist Heat or Steam Sterilization

[00821925003149]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-14

On-Brand Devices [USA Elite System™ Rotating Continuous Flow Resectoscope Timberlake Ob]

• 00821925003156: ERTO-CF27 Rotating CF Obturator, 27Fr
• 00821925003149: ERTO-CF25 OBTURATOR TIMBER CF ROT 25FR