Wallach Endocell

GUDID 00888937011241

Endometrial Cell Sampler

Coopersurgical, Inc.

Endometrial biopsy kit

• Primary Device ID: 00888937011241
• NIH Device Record Key: 62259ef8-353e-40b1-900b-4cef730fe8f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wallach Endocell
• Version Model Number: 908014A
• Company DUNS: 801895244
• Company Name: Coopersurgical, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937011241 [Primary]
GS1	20888937011245 [Package]; Package: [35 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K902693

FDA Product Code

• HFF: Aspirator, Endometrial

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-16

On-Brand Devices [Wallach Endocell]

• 30888937011266: Endometrial Cell Sampler
• 30888937011259: Endometrial Cell Sampler
• 00888937011241: Endometrial Cell Sampler