Medscand Pap-Perfect Supply Tray

Primary DI
20888937009891
Brand
Medscand Pap-Perfect Supply Tray
Company
Coopersurgical, Inc.
Model
60115-20/25
Device description
Cytobrush Plus GT
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
HHTSpatula, Cervical, Cytological

Product Code Classifications

CodeDeviceSpecialtyClass
HHTSpatula, Cervical, CytologicalObstetrics/Gynecology2

Premarket Submissions

SubmissionSupplement
K832986000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K832986000PAP SMEAR BRUSHDonald G. Zeller1984-02-10HHT

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20888937009891PackageGS120In Commercial Distribution
60888937009899PrimaryGS10
00888937009897Unit of UseGS10

GMDN Terms

TermDefinition
Papanicolaou smear kitA packaged collection of instruments, equipment, and reagents required to obtain a cytology sample from the cervix and perform a Papanicolaou test (PAP). Commonly known as a Pap smear or Pap test the cells are typically smeared onto a microscope slide or mixed in a liquid fixative for microscopic examination. A Pap test is usually done as part of a woman's regular pelvic examination. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
801895244
Device count
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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