DEVICE: BEAR (G043801010)

Device Identifier (DI) Information

BEAR
8.01.01
In Commercial Distribution
8.01.01
Bear-Ent, LLC
G043801010
HIBCC

1
123551586 *Terms of Use
Grooved Director with Probe, 14.5cm
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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?
46486 Gastro-urological director
A slender, rod-like surgical instrument made of metal, typically with groove running along the centre of it distal shaft and/or continuing with an elongated malleable wire loop, that is used to guide other devices or instruments into a selected intracorporeal location during a gastroenterological/urological (GU) procedure. The distal shaft may be straight or curved and the proximal handle formed as a finger grip. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FGM Probe And Director, Gastro-Urology
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FDA Premarket Submission

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

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

be811b58-1be7-43e2-bd49-578b3e44e47b
November 15, 2022
1
November 07, 2022
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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
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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

[?]
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
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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