DEVICE: CrossGlide ETS (00850012760054)

Device Identifier (DI) Information

CrossGlide ETS
CBPN3001
In Commercial Distribution

CROSS BAY MEDICAL, INC.
00850012760054
GS1

1
065552991 *Terms of Use
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.
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Device Characteristics

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

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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?
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.
Active false
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FDA Product Code

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Product Code Product Code Name
HHK Curette, Suction, Endometrial (And Accessories)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K192534 000
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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

23a65bb5-c7d0-488c-bdaf-1f50d82bcc5c
October 26, 2021
1
October 18, 2021
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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
10850012760051 5 00850012760054 In Commercial Distribution Shelf carton
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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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