AccessGUDID - DEVICE: Andwin Scientific (00187207000191)

GUDID

Device Identifier (DI) Information

Brand Name: Andwin Scientific
Version or Model: 240080
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Andwin Scientific

Primary DI Number: 00187207000191
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 028449445 *Terms of Use

Device Description: PAPKIT, 5035X, 2 Slide, Brush, Scraper, CTA & Fix Pouch

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
12955	Papanicolaou smear kit	A 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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
OHL	Pap Smear Kit
HHT	Spatula, Cervical, Cytological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K890283	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 80eb6fa6-2cf7-4d09-b231-b9bc3cc0626f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 02, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20187207000195	20	10187207000198		In Commercial Distribution	CASE
10187207000198	25	00187207000191		In Commercial Distribution	INNER PACK

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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