KOLPLAST

GUDID 07898027905902

"Cervical Sample Collection Kit, intended for collection of cytological specimens from the ectocervix and the endocervix."

Kolplast C I

Papanicolaou smear kit

• Primary Device ID: 07898027905902
• NIH Device Record Key: 6a5cb172-69e3-4a5c-9426-71b0adfd35ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KOLPLAST
• Version Model Number: Standard
• 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

Customer Support Contacts

• Phone: +551149610972
• Email: daniela.feracin@kolplast.com.br
• Phone: +551149610972
• Email: daniela.feracin@kolplast.com.br
• Phone: +551149610972
• Email: daniela.feracin@kolplast.com.br
• Phone: +551149610972
• Email: daniela.feracin@kolplast.com.br
• Phone: +551149610972
• Email: daniela.feracin@kolplast.com.br
• Phone: +551149610972
• Email: daniela.feracin@kolplast.com.br
• Phone: +551149610972
• Email: daniela.feracin@kolplast.com.br
• Phone: +551149610972
• Email: daniela.feracin@kolplast.com.br
• Phone: +551149610972
• Email: daniela.feracin@kolplast.com.br
• Phone: +551149610972
• Email: daniela.feracin@kolplast.com.br
• Phone: +551149610972
• Email: daniela.feracin@kolplast.com.br
• Phone: +551149610972
• Email: daniela.feracin@kolplast.com.br
• Phone: +551149610972
• Email: daniela.feracin@kolplast.com.br
• Phone: +551149610972
• Email: daniela.feracin@kolplast.com.br
• Phone: +551149610972
• Email: daniela.feracin@kolplast.com.br
• Phone: +551149610972
• Email: daniela.feracin@kolplast.com.br
• Phone: +551149610972
• Email: daniela.feracin@kolplast.com.br
• Phone: +551149610972
• Email: daniela.feracin@kolplast.com.br

Device Identifiers

Device Issuing Agency	Device ID
GS1	07898027905902 [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: 2019-09-23
• Device Publish Date: 2019-09-13

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