FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD32154090
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD3215409
Catalog number
SD3215409
Device description
7 1/2 Inch Medium/ Large Green Clip appliers, Straight
Published
2022-11-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDOApplier, surgical, clip

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDOApplier, Surgical, ClipGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD32154090PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery ligation clip applierA hand-held manual surgical instrument designed to apply small atraumatic clips (not included) for the ligation of blood vessels, or similar tubular anatomy, mainly to prevent and/or stop bleeding (i.e., haemostasis) during an open-surgery procedure. It may also be used to apply small clamps (e.g., bulldog type) to tissues however it is not intended to apply an aneurysm clip. The device is typically a metallic instrument with flat, curved ends to hold and deliver the clips (e.g., forceps-like); implantable clips are not included. This is a reusable device after sterilization.

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382SD512531140Surgical DirectSD51253114SD512531142026-02-03
B382SD77321140Surgical DirectSD7732114SD77321142026-02-03
B382SD97321140Surgical DirectSD9732114SD97321142026-02-02
B382SD97321150Surgical DirectSD9732115SD97321152026-02-02
B382SD97331160Surgical DirectSD9733116SD97331162026-02-02
B382SD51531140Surgical DirectSD5153114SD51531142025-12-02
B382SD65331140Surgical DirectSD6533114SD65331142025-12-02
B382SD67511170Surgical DirectSD6751117SD67511172025-06-04
B382SD95321140Surgical DirectSD9532114SD95321142025-06-04
B382SD84531130Surgical DirectSD8453113SD84531132025-04-03
B382SD92422150Surgical DirectSD9242215SD92422152025-03-17
B382SD512531150Surgical DirectSD51253115SD512531152025-03-10
B382SD123200Surgical DirectSD12320SD123202024-12-12
B382SD52321110Surgical DirectSD5232111SD52321112024-08-08
B382SD82421110Surgical DirectSD8242111SD82421112024-08-01
B382SD81531140Surgical DirectSD8153114SD81531142024-03-12
B382SD82131160Surgical DirectSD8213116SD82131162024-03-12
B382SD42531170Surgical DirectSD4253117SD42531172024-02-23
B382SD4810450Surgical DirectSD481045SD4810452024-01-31
B382SD77311150Surgical DirectSD7731115SD77311152023-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800042700065Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042700904Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042700911Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042700928Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042701369Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042701376Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042701390Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042701406Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702878Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702885Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702892Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702908Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702915Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702922Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08809756910081Artisential Clip Applier LargeLIVSMEDGDO2026-04-21
08809756910104Artisential Clip Applier LargeLIVSMEDGDO2026-04-21
10381780540595CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDO2026-04-15
10381780540601CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDO2026-04-15
G58690311220Novo SurgicalNOVO SURGICAL, INC.GDO2025-03-25
10381780544302CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDO2024-10-02
14026704738110WECKTELEFLEX INCORPORATEDGDO2024-07-17
14026704726384WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726391WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726407WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726414WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726421WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726438WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726445WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726452WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726469WECKTELEFLEX INCORPORATEDGDO2024-03-13