VAGISPEC KOLPLAST 10.1392

GUDID 07898027907166

Kolplast C I

Vaginal speculum, single-use Vaginal speculum, single-use Vaginal speculum, single-use Vaginal speculum, single-use Vaginal speculum, single-use Vaginal speculum, single-use Vaginal speculum, single-use Vaginal speculum, single-use Vaginal speculum, single-use Vaginal speculum, single-use Vaginal speculum, single-use Vaginal speculum, single-use Vaginal speculum, single-use Vaginal speculum, single-use Vaginal speculum, single-use Vaginal speculum, single-use Vaginal speculum, single-use Vaginal speculum, single-use

• Primary Device ID: 07898027907166
• NIH Device Record Key: 49216b2f-9688-4c78-a968-26c00dcce523
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VAGISPEC KOLPLAST
• Version Model Number: ESPEC VAG KOLP G KOLPLUX NE
• Catalog Number: 10.1392
• Company DUNS: 903963889
• Company Name: Kolplast C I
• 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: true
• Expiration Date: true
• 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	07898027907166 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973853

FDA Product Code

• HIB: Speculum, Vaginal, Nonmetal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-07
• Device Publish Date: 2023-11-29

On-Brand Devices [VAGISPEC KOLPLAST]

• 07898027909108: ESPECULO VAG KOLPLAST M NN NE
• 07898027907951: ESPECULO VAGINAL GRANDE
• 07898027907333: ESPECULO VAG KOLPLAST G CAF E
• 07898027907326: ESPECULO VAG KOLPLAST M CAF E
• 07898027907166: ESPEC VAG KOLP G KOLPLUX NE
• 07898027907159: ESPEC VAG KOLP M KOLPLUX NE 25
• 07898027907074: ESPEC VAG KOLP M KOLPLUX NE
• 07898027906312: ESPECULO VAG KOLPLAST G NE
• 07898027906015: ESPECULO VAG KOLPLAST M NE
• 07898027905988: ESPECULO VAG KOLPLAST P NE
• 07898027904127: ESPEC VAG VAGISPEC M E LUB
• 07898027904110: ESPECULO VAG KOLPLAST M E
• 07898027903687: ESPEC VAG VAGISPEC G E NLUB
• 07898027903663: ESPEC VAG VAGISPEC P E LUB
• 07898027903656: ESPEC VAG VAGISPEC P NLUB E
• 07898027903038: ESPECULO VAG KOLPLAST VIRGEM E
• 07898027902161: ESPEC VAG KOLPLAST G LONGO EST
• 07898027902154: ESPEC VAG KOLPLAST G LONGO
• 07898027902130: ESPEC VAG VAGISPEC G LUB E