DEVICE: Surgical Direct (B382SD89959080)

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Device Record History
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Device Identifier (DI) Information
Surgical Direct
SD8995-908
In Commercial Distribution
SD8995-908
Surgical Direct, Inc.
B382SD89959080
HIBCC

1
124367223 *Terms of Use
5mm Curved Medium Dissector, 17.8mm Jaw Length; Modular; Two Piece; Ratchet ON - Demand Comfort Handle with Free Rotation; Standard Length
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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?
62667 Laparoscopic tissue manipulation forceps/working-channel
A rigid, hand-held manual surgical instrument designed to be introduced through a laparoscope/laparoscopic port for: 1) atraumatic grasping/clamping of soft tissues (e.g., gallbladder); and 2) access adjacent to the site of clamping (e.g., during laparoscopic cholangiography). It is a hand-held device with proximal handles, a rigid long slender shaft with a built-in working-channel, and distal grasping blades. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GEI Electrosurgical, cutting & coagulation & accessories
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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
c34aa26c-602a-4e72-a544-d4581d9da69d
November 12, 2025
1
November 04, 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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