FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD13108150
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD13108-15
Catalog number
SD13108-15
Device description
5mm Standard Grasper with Cup, 11.7mm Jaw Length; Modular; Three Piece; Comfort Grip, Carbon Fiber, Reinforced Handle, Rotating with On/Off Ratchet; Standard Length
Published
2026-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
B382SD13108150PrimaryHIBCC0

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382SD15908450Surgical DirectSD 1590845SD 15908452026-10-30
B382SD32154290Surgical DirectSD3215429SD32154292026-10-30
B382SD902405100Surgical DirectSD90240510SD902405102026-10-30
B382SD914178350Surgical DirectSD91417835SD914178352026-10-30
B382SD9144841120Surgical DirectSD914484112SD9144841122026-10-30
B382SD9144841140Surgical DirectSD914484114SD9144841142026-10-30
B382SD9144841250Surgical DirectSD914484125SD9144841252026-10-30
B382SD9144842000Surgical DirectSD914484200SD9144842002026-10-30
B382SD9144842010Surgical DirectSD914484201SD9144842012026-10-30
B382SD9144842020Surgical DirectSD914484202SD9144842022026-10-30
B382SD9144842030Surgical DirectSD914484203SD9144842032026-10-30
B382SD9144842040Surgical DirectSD914484204SD9144842042026-10-30
B382SD9144843000Surgical DirectSD914484300SD9144843002026-10-30
B382SD9144843010Surgical DirectSD914484301SD9144843012026-10-30
B382SD9144843020Surgical DirectSD914484302SD9144843022026-10-30
B382SD9144843030Surgical DirectSD914484303SD9144843032026-10-30
B382SD9144843040Surgical DirectSD914484304SD9144843042026-10-30
B382SD914763020Surgical DirectSD91476302SD914763022026-10-30
B382SD915584140Surgical DirectSD91558414SD915584142026-10-30
B382SD92006332E0Surgical DirectSD92006332ESD92006332E2026-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048551431603n.a.Karl Storz GmbH & Co. KGGCJ2026-11-02
08904332600803MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGCJ2026-11-02
B382SD15908450Surgical DirectSurgical Direct, Inc.GCJ2026-10-30
B382SD32154290Surgical DirectSurgical Direct, Inc.GCJ2026-10-30
B382SD13517450Surgical DirectSurgical Direct, Inc.GCJ2026-10-28
B382SD13518130Surgical DirectSurgical Direct, Inc.GCJ2026-10-28
B382SD15908130Surgical DirectSurgical Direct, Inc.GCJ2026-10-28
B382SD77505940Surgical DirectSurgical Direct, Inc.GCJ2026-10-28
00190776436827MillenniumAvalign Technologies, Inc.GCJ2026-10-22
B382SD772553050Surgical DirectSurgical Direct, Inc.GCJ2026-10-22
00190776435677MillenniumAvalign Technologies, Inc.GCJ2026-10-21
00190776435684MillenniumAvalign Technologies, Inc.GCJ2026-10-21
00190776435493MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435547MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435295MillenniumAvalign Technologies, Inc.GCJ2026-10-19
00190776435455MillenniumAvalign Technologies, Inc.GCJ2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
04548736175013OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175068OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175112OLYMPUSSONY CORPORATIONGCJ2026-10-15
00190776434922MillenniumAvalign Technologies, Inc.GCJ2026-10-14
00190776434823MillenniumAvalign Technologies, Inc.GCJ2026-10-13
00190776434854MillenniumAvalign Technologies, Inc.GCJ2026-10-13
B382SD56300680Surgical DirectSurgical Direct, Inc.GCJ2026-10-13