FDA.reportPublic FDA data

Andwin Scientific

Primary DI
20187207000089
Brand
Andwin Scientific
Company
Andwin Scientific
Model
231057
Device description
PAPKIT, CLASSIC, 5053xcp, 1 Slide, Scraper, Brush & Fixative Pack
Published
2017-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
OHLPap Smear Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHLPap Smear KitObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K890283000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K890283000CYTEX ONE AND CYTEX TWOAnderson Winn Paper Co.1989-03-16HHT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10187207000082PackageGS125In Commercial Distribution
20187207000089PackageGS120In Commercial Distribution
00187207000085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1018720700008210187207000082
2018720700008920187207000089
00187207000085001872070000851872070000850187207000085

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
028449445
Device count
1
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00187207000467SealSafe760024P2025-08-14
00187207000474SealSafe760024S2025-08-14
00187207000481SealSafe760020P2025-08-14
00187207000498SealSafe760020S2025-08-14
00187207000504SealSafe760028P2025-08-14
00187207000511SealSafe760028S2025-08-14
00187207000351Andwin 8901812019-05-22
00187207000382Andwin Scientific8901832019-05-22
00187207000412Andwin Scientific8901852019-05-22
20187207000362Andwin Scientific8901822019-05-22
20187207000393Andwin Scientific8901842019-05-22
20187207000423Andwin Scientific8901862019-05-22
30187207000437Andwin Scientific8901872019-05-22
00187207000085Andwin Scientific2310572017-08-02
00187207000092Andwin Scientific2301102017-08-02
00187207000108Andwin Scientific2301002017-08-02
00187207000122Andwin Scientific2301802017-08-02
00187207000139Andwin Scientific2300802017-08-02
00187207000146Andwin Scientific2300752017-08-02
00187207000153Andwin Scientific2301602017-08-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10195594077877CARDINAL HEALTHCardinal Health 200, LLCOHL2021-06-07
50195594077875CARDINAL HEALTHCardinal Health 200, LLCOHL2021-06-07
10810010890471Aero-MedAERO-MED, LLCOHL2019-01-16
10810010890501Aero-MedAERO-MED, LLCOHL2019-01-16
50810010890479Aero-MedAERO-MED, LLCOHL2019-01-16
50810010890509Aero-MedAERO-MED, LLCOHL2019-01-16
10888439311617CARDINAL HEALTHCardinal Health 200, LLCOHL2019-01-14
50888439311615CARDINAL HEALTHCardinal Health 200, LLCOHL2019-01-14
10887488944845CARDINAL HEALTHCardinal Health 200, LLCOHL2018-04-30
50887488944843CARDINAL HEALTHCardinal Health 200, LLCOHL2018-04-30
10809160158739Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OHL2017-08-11
10809160159125Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OHL2017-08-11
20809160159122Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OHL2017-08-11
00187207000085Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000092Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000108Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000122Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000139Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000146Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000153Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000160Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000177Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000184Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000191Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000207Andwin ScientificAndwin ScientificOHL2017-08-02
00187207000078Andwin ScientificAndwin ScientificOHL2017-08-02
20187207000096Andwin ScientificAndwin ScientificOHL2017-08-02
20187207000102Andwin ScientificAndwin ScientificOHL2017-08-02
20187207000126Andwin ScientificAndwin ScientificOHL2017-08-02
20187207000133Andwin ScientificAndwin ScientificOHL2017-08-02