DEVICE: CrossGlide ETS (00850012760054)
Device Identifier (DI) Information
CrossGlide ETS
CBPN3001
In Commercial Distribution
CROSS BAY MEDICAL, INC.
CBPN3001
In Commercial Distribution
CROSS BAY MEDICAL, INC.
The CrossGlide Endometrial Tissue Sampler (ETS) is comprised of a Delivery Catheter with a 6 Fr Biopsy Device and everting
membrane that accesses the cervix and uterine cavity and a 3cc syringe with an attachable compliant tube assembly for supplying
saline to the Delivery Catheter. The 3cc syringe is also used for supplying negative pressure in the ETS. The Delivery Catheter
contains an acorn tip as an aid in seating its distal end at the exocervix.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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11531 | Endometrial biopsy kit |
A collection of sterile devices designed for the collection of a tissue sample taken from the lining of the uterus (endometrium). It typically includes an aspirating curette, a specimen container and other materials. It is used in the study of endometrial cytology (cells). This is a single-use device.
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FDA Product Code
[?]Product Code | Product Code Name |
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HHK | Curette, Suction, Endometrial (And Accessories) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K192534 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
23a65bb5-c7d0-488c-bdaf-1f50d82bcc5c
October 26, 2021
1
October 18, 2021
October 26, 2021
1
October 18, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10850012760051 | 5 | 00850012760054 | In Commercial Distribution | Shelf carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined