FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD050100
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD05010
Catalog number
SD05010
Device description
Laparoscopic Instrument and Scope Holder, Flex Arm, 760mm
Published
2022-11-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, general & plastic surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K974382000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974382000ACKERMANN SURGICAL INSTRUMENTSAckermann Instrumente GmbH1998-04-21GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD050100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Externally-anchored laparoscopic retractorA non-sterile, intraoperative surgical instrument designed for use during laparoscopic procedures to provide hands-free retraction of lower abdominal, urogenital or pelvic structures. It is inserted into the abdominal cavity through a small dedicated incision and manoeuvred into place under direct laparoscopic vision to lift the urogenital structures, and then anchored external to the body to a fixation device typically attached to the operating table. It is typically made of metal (e.g., stainless steel) and is in the form of a rod shaped to form a saddle-shaped hook, and may be available in left and right configurations. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 519-3293info@surgicaldirect.com

Regulatory Flags#

DUNS number
124367223
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382SD9207261140Surgical DirectSD920726114SD9207261142022-12-05
B382SD905500140Surgical DirectSD90550014SD905500142022-11-30
B382SD017210000Surgical DirectSD0172-1000SD0172-10002026-08-21
B382SD13448970Surgical DirectSD13448-97SD13448-972026-08-21
B382SD16008970Surgical DirectSD16008-97SD16008-972026-08-21
B382SD161730Surgical DirectSD1617-3SD1617-32026-08-21
B382SD3028P0Surgical DirectSD3028PSD3028P2026-08-21
B382SD77205052000Surgical DirectSD77205-05-200SD77205-05-2002026-08-21
B382SD77205082000Surgical DirectSD77205-08-200SD77205-08-2002026-08-21
B382SD7720508TS2000Surgical DirectSD77205-08TS-200SD77205-08TS-2002026-08-21
B382SD77205252000Surgical DirectSD77205-25-200SD77205-25-2002026-08-21
B382SD83042110011NS0Surgical DirectSD83042-11001-1NSSD83042-11001-1NS2026-08-21
B382SD9017971000Surgical DirectSD901797100SD9017971002026-08-21
B382SD907300000Surgical DirectSD90730000SD907300002026-08-21
B382SD914775290Surgical DirectSD91477529SD914775292026-08-21
B382SD915039080Surgical DirectSD91503908SD915039082026-08-21
B382SD915039140Surgical DirectSD91503914SD915039142026-08-21
B382SD915039150Surgical DirectSD91503915SD915039152026-08-21
B382SD9227656000Surgical DirectSD922765600SD9227656002026-08-21
B382SD9144941010Surgical DirectSD914494101SD9144941012026-08-14

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Primary DI, Brand, Company table
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