DEVICE: SpiraBrush CX (00860275000309)

Device Identifier (DI) Information

SpiraBrush CX
SBX-9000
In Commercial Distribution
SBX-9000
HISTOLOGICS, LLC
00860275000309
GS1

1
023001257 *Terms of Use
SpiraBrush CX is intended for obtaining a biopsy of visible exocervical lesions for the purpose of obtaining tissue diagnosis in women with intraepithelial disease.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Cervical cytology scraper, single-use A hand-held, manual, blunt surgical instrument designed to scrape and retrieve cytological material from the surface of the cervix (neck of the uterus) or vaginal area for pathological examination and diagnosis, often for the detection of cervical cancer. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
HFB Forceps, Biopsy, Gynecological
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K011488 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

1c44b40c-03f0-4a88-910e-55438bdb76fd
July 06, 2018
3
September 28, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
888-738-9757
Histologics@gmail.com
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