KOLPLAST TPCAP25

GUDID 07898027908460

Kolplast C I

General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit

• Primary Device ID: 07898027908460
• NIH Device Record Key: c9a21a66-99ca-435b-ba3b-cbd6ca881a1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KOLPLAST
• Version Model Number: ESCOVA PP/ESPATULA PLAST 25UN
• Catalog Number: TPCAP25
• 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	07898027908460 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153128

FDA Product Code

• HHT: Spatula, Cervical, Cytological

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 [KOLPLAST]

• 07898027905902: "Cervical Sample Collection Kit, intended for collection of cytological specimens from the ectoc
• 07898027903601: Wireless LED light source for vaginal speculum. Provides illumination during pelvic examination
• 07898027903526: LED light source for vaginal speculum. Provides illumination during pelvic examination and other
• 07898027903519: Disposable Vaginal Speculum
• 07898027909894: SWAB HASTE NASAL D2,5 ESTERIL
• 07898027908682: SOL SALINA 3ML/2SWAB T10 EST
• 07898027908460: ESCOVA PP/ESPATULA PLAST 25UN
• 07898027905353: SWAB HASTE REGULAR D2,5 FP EST
• 07898027903311: RETOSIGMOIDOSCOPIO
• 07898027901355: RETOSIGMOIDOSCOPIO