DEVICE: Surgical Direct (B382SD8400540)

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Device Record History
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Device Identifier (DI) Information
Surgical Direct
SD840-054
In Commercial Distribution
SD840-054
Surgical Direct, Inc.
B382SD8400540
HIBCC

1
124367223 *Terms of Use
4mm 0° Sinuscope, Autoclavable, HD, German Made, 170mm Length, Wolf Fit
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
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?
43053 Rigid video laparoscope
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the organs/structures of the abdominal/retroperitoneal cavity. It is inserted through a dedicated incision made in the abdominal wall during laparoscopy. Images are transmitted by a camera/video system to a monitor for viewing by the user. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HRX Arthroscope
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K031972 000
No 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
8576e3d7-5932-4e58-b7af-77c0f48361c4
September 24, 2025
1
September 16, 2025
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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

[?]
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

[?]
+1 (800) 519-3293
info@surgicaldirect.com
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