FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD48155416201210
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD4815541620-121
Catalog number
SD4815541620-121
Device description
6.5mm 175mm Pyramidal Trocar, Stryker Style
Published
2022-11-30
Public version status
Update
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
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031972000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031972000ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00,Asap Endoscopic Products GmbH2003-09-15HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD48155416201210PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope sheath, reusableA component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. This is a reusable device.

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
B382SD9226391030Surgical DirectSD922639103SD9226391032023-02-22
B382SD9192442700Surgical DirectSD919244270SD9192442702022-12-01
B382SD180190Surgical DirectSD18019SD180192020-04-29
B382SD180290Surgical DirectSD18029SD180292020-04-28
B382SD182490Surgical DirectSD18249SD182492020-04-29
B382SD182590Surgical DirectSD18259SD182592020-04-25
B382S25681060Surgical DirectS2568.106S2568.1062026-07-29
B382S340861270Surgical DirectS34086.127S34086.1272026-07-29
B382SD90557818E0Surgical DirectSD90557818ESD90557818E2026-07-29
B382SD90712216T0Surgical DirectSD90712216TSD90712216T2026-07-29
B382SD914709040Surgical DirectSD91470904SD914709042026-07-29
B382SD919327220Surgical DirectSD91932720SD919327202026-07-29
B382SD919327230Surgical DirectSD91932723SD919327232026-07-29
B382SD919523070Surgical DirectSD91952307SD919523072026-07-29
B382SD919523080Surgical DirectSD91952308SD919523082026-07-29
B382SD9196141000Surgical DirectSD919614100SD9196141002026-07-29
B382SD9196141010Surgical DirectSD919614101SD9196141012026-07-29
B382SD9200321000Surgical DirectSD920032100SD9200321002026-07-29
B382SD9200321060Surgical DirectSD920032106SD9200321062026-07-29
B382SD9200321070Surgical DirectSD920032107SD9200321072026-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809695579813Trocar Needle (Working Channel)GS Medical Co., Ltd.HRX2026-07-27
08809695579820Bevel Needle (Working Channel)GS Medical Co., Ltd.HRX2026-07-27
00190776422059MillenniumAvalign Technologies, Inc.HRX2026-07-24
00190776422066MillenniumAvalign Technologies, Inc.HRX2026-07-24
10810004821085Spinal Needle SetCLARUS MEDICAL, LLCHRX2026-06-23
10810004821146Curved Cannula SetCLARUS MEDICAL, LLCHRX2026-06-23
00810004821101Digital SpineScope EndoscopeCLARUS MEDICAL, LLCHRX2026-06-22
10810004821122Spinal Introducer SetCLARUS MEDICAL, LLCHRX2026-06-22
00846338001209IEC BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-03
00846338001230Bipolar CableELLIQUENCE, LLCHRX2026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCHRX2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCHRX2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCHRX2026-06-03
00846338001629IEC Power Cord U.K. 220vELLIQUENCE, LLCHRX2026-06-03
00846338007140BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-02
00846338005146Neutral PlateELLIQUENCE, LLCHRX2026-06-01
00846338005320Needle PunchELLIQUENCE, LLCHRX2026-06-01
10845854035559E9000Conmed CorporationHRX2026-03-24
07613327601695Connected OR HubSTRYKER CORPORATIONHRX2025-06-04
07613327601701SDC4K Information Management SystemSTRYKER CORPORATIONHRX2025-06-04
07613327638226OmnicurveSTRYKER CORPORATIONHRX2024-09-03
07613327638233OmnicurveSTRYKER CORPORATIONHRX2024-09-03
07613327638240OmnicurveSTRYKER CORPORATIONHRX2024-09-03
07613327638257OmnicurveSTRYKER CORPORATIONHRX2024-09-03
07613327638431OmnicurveSTRYKER CORPORATIONHRX2024-09-03
07613327638448OmnicurveSTRYKER CORPORATIONHRX2024-09-03
B235MDK00020mild Device KitSTRYKER CORPORATIONHRX2024-06-19
08800038059313SYNTH™ STANDARDIMEDICOM CO., LTD.HRX2024-03-25