AccuTip Cover AX9950

GUDID 00897826002086

Individually wrapped

ACCUTOME, INC.

Ophthalmic tonometer tip cover

• Primary Device ID: 00897826002086
• NIH Device Record Key: c4117e4f-c21e-4e0e-a99d-c3448e06425c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuTip Cover
• Version Model Number: AX9950
• Catalog Number: AX9950
• Company DUNS: 048792816
• Company Name: ACCUTOME, INC.
• Device Count: 100
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00897826002086 [Primary]
GS1	00897826002130 [Unit of Use]

FDA Product Code

• HKY: Tonometer, Manual

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-11-29
• Device Publish Date: 2016-09-13

On-Brand Devices [AccuTip Cover]

• 00897826002116: Bulk, non-sleeved
• 00897826002109: Sleeved
• 00897826002093: Individually wrapped
• 00897826002086: Individually wrapped