DEVICE: BR Surgical, LLC (00840183515317)

Device Identifier (DI) Information

BR Surgical, LLC
BR981-26050
In Commercial Distribution
BR981-26050
BR Surgical, LLC
00840183515317
GS1

1
134781207 *Terms of Use
Disposable Biopsy Valve, for Olympus and Fujinon GI Endoscopes, single use, non sterile, latex free, 10/pk
CLOSE

Device Characteristics

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

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?
62145 Endoscope working-channel valve, single-use
A device in the form of a small attachment intended to be fitted to the working channel (including biopsy port) of an endoscope to enable access for, and/or exchange of, an endoscopic device while minimizing leakage of liquids and gasses during an endoscopic procedure. Also referred to as a seal, it may be Luer formatted and include features to allow for simultaneous irrigation/biopsy or suction via the working channel. This is a single-use device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
QFZ Gastroenterology-Urology Accessories To A Biopsy Instrument
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

b8deb375-ce6a-452d-b37b-6212d3decdf1
July 30, 2024
1
July 22, 2024
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

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

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
1-904-642-1366
customerservice@brsurgical.com
CLOSE