FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD999740
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD99974
Catalog number
SD99974
Device description
5mm Johan Fenestrated Grasper, 34.97mm Jaw Rotatable, Slide-lock Handle, Standard Length
Published
2024-03-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K914910000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914910000DAVOL LAPAROSCOPIC INSTRUMENTS (GEN SURG REUSABLE)Davol, Inc.1992-01-06GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD999740PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic tissue manipulation forceps/working-channelA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length33Centimeter
Outer Diameter5Millimeter

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
B382SD309390Surgical DirectSD30939SD309392026-10-20
B382SD4810110Surgical DirectSD48-1011SD48-10112026-10-20
B382SD62362020Surgical DirectSD62362-02SD62362-022026-10-20
B382SD907310070Surgical DirectSD90731007SD907310072026-10-20
B382SD915070010Surgical DirectSD91507001SD915070012026-10-20
B382SD915070020Surgical DirectSD91507002SD915070022026-10-20
B382SD915070030Surgical DirectSD91507003SD915070032026-10-20
B382SD915758300Surgical DirectSD91575830SD915758302026-10-20
B382SD917665100Surgical DirectSD91766510SD917665102026-10-20
B382SD917665110Surgical DirectSD91766511SD917665112026-10-20
B382SD917665120Surgical DirectSD91766512SD917665122026-10-20
B382SD917665700Surgical DirectSD91766570SD917665702026-10-20
B382SD917665920Surgical DirectSD91766592SD917665922026-10-20
B382SD917665930Surgical DirectSD91766593SD917665932026-10-20
B382SD9210921080Surgical DirectSD921092108SD9210921082026-10-20
B382SD922624103T0Surgical DirectSD922624103TSD922624103T2026-10-20
B382SD9228132200Surgical DirectSD922813220SD9228132202026-10-20
B382SD9228132210Surgical DirectSD922813221SD9228132212026-10-20
B382SD9228132220Surgical DirectSD922813222SD9228132222026-10-20
B382SD9228132300Surgical DirectSD922813230SD9228132302026-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B108499AP1MRA1MUS00Large applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA2MUS00Small applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA45MUS00Edge applicatorsBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499PO1MUS00BTL-499-1BTL INDUSTRIES LIMITEDGEI2026-10-20
00190776435288MillenniumAvalign Technologies, Inc.GEI2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
00860016247000Super PencilRF KINETICS LLCGEI2026-10-17
00860016247017Super PencilRF KINETICS LLCGEI2026-10-17
00860016247024Super PencilRF KINETICS LLCGEI2026-10-17
00860016247031Super PencilRF KINETICS LLCGEI2026-10-17
00841019124017KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124024KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124048KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124079KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124086KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124093KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124109KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124116KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124123KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124130KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
10381780533276Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
10381780533283Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
00190776435028MillenniumAvalign Technologies, Inc.GEI2026-10-14
00190776434878MillenniumAvalign Technologies, Inc.GEI2026-10-13