FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD903780200
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD90378020
Catalog number
SD90378020
Device description
"5 3/8"" Westcott-Type Utility Scissors, 24mm Blade, Long Handle"
Published
2024-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EGNSCISSORS, SURGICAL TISSUE, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGNScissors, Surgical Tissue, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD903780200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical scissors, single-useA hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a single-use 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382SD883110450Surgical DirectSD88311045SD883110452026-07-10
B382SD88324450Surgical DirectSD8832445SD88324452026-07-10
B382SD9032161000Surgical DirectSD903216100SD9032161002026-07-10
B382SD90390213SC0Surgical DirectSD90390213SCSD90390213SC2026-07-10
B382SD9044561000Surgical DirectSD904456100SD9044561002026-07-10
B382SD92268003T0Surgical DirectSD92268003TSD92268003T2026-07-10
B382SD92268030T0Surgical DirectSD92268030TSD92268030T2026-07-10
B382SD92268031T0Surgical DirectSD92268031TSD92268031T2026-07-10
B382SD92268032T0Surgical DirectSD92268032TSD92268032T2026-07-10
B382SD92268033T0Surgical DirectSD92268033TSD92268033T2026-07-10
B382SD92268034T0Surgical DirectSD92268034TSD92268034T2026-07-10
B382SD92268035T0Surgical DirectSD92268035TSD92268035T2026-07-10
B382SD92268036T0Surgical DirectSD92268036TSD92268036T2026-07-10
B382SD92268037T0Surgical DirectSD92268037TSD92268037T2026-07-10
B382SD92268038T0Surgical DirectSD92268038TSD92268038T2026-07-10
B382SD92268039T0Surgical DirectSD92268039TSD92268039T2026-07-10
B382SD92268040T0Surgical DirectSD92268040TSD92268040T2026-07-10
B382SD92268041T0Surgical DirectSD92268041TSD92268041T2026-07-10
B382SD92268042T0Surgical DirectSD92268042TSD92268042T2026-07-10
B382SD92268043T0Surgical DirectSD92268043TSD92268043T2026-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841013124716MicroquoreAMERICAN EAGLE INSTRUMENTS, INC.EGN2026-06-26
B382S37841020Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382S37842000Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382S37935000Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD903070100SC0Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD903071100SC0Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD90315118T0Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9034541060Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9035521000Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9035651000Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9037861000Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9037871010Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD903797030Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD903870060Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9039790010Surgical DirectSurgical Direct, Inc.EGN2026-06-10
B382SD9039871000Surgical DirectSurgical Direct, Inc.EGN2026-06-10
04059453162762Hermann Medizintechnik GmbHHermann Medizintechnik GmbHEGN2026-05-29
G149NPGFS0NPSACME ENTERPRISE.EGN2026-05-01
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08961104625945MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22