Vaginal Speculum

GUDID 00616784491639

DYNAREX CORPORATION

Vaginal speculum, single-use

• Primary Device ID: 00616784491639
• NIH Device Record Key: e74e60b6-d300-4f54-a0c4-ba0333c98515
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vaginal Speculum
• Version Model Number: 4916
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 20
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784491615 [Unit of Use]
GS1	00616784491622 [Primary]
GS1	00616784491639 [Package]; Contains: 00616784491622; Package: [20 Units]; In Commercial Distribution

FDA Product Code

• HIB: Speculum, Vaginal, Nonmetal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

On-Brand Devices [Vaginal Speculum]

• 00616784491639: 4916
• 00616784491530: 4915
• 00616784491431: 4914
• 00616784491332: 4913
• 00616784491233: 4912
• 00616784491134: 4911