SlimLine™ Continuous Flow Operative Hysteroscope Outer Sheath

GUDID 00821925007253

Gyrus Acmi, Inc.

Rigid optical hysteroscope

• Primary Device ID: 00821925007253
• NIH Device Record Key: 0f8ecb6b-4bf6-4fab-af07-1784137c90f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SlimLine™ Continuous Flow Operative Hysteroscope Outer Sheath
• Version Model Number: REXGY275L-S
• 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	00821925007253 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K890328

FDA Product Code

• FAS: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• HIH: Hysteroscope (And Accessories)

Sterilization

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

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

[00821925007253]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-10-06

On-Brand Devices [SlimLine™ Continuous Flow Operative Hysteroscope Outer Sheath]

• 00821925007253: REXGY275L-S
• 00821925001831: GY275L-S SlimLine Outer Sheath 5.5mm