FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD32000
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD3200
Catalog number
SD3200
Device description
Visualus, Fiber Optic, Surgical Headlight, 90° Headlight, Detachable Joysticks, Bifurcated Cable, 9f
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
FSTLIGHT, SURGICAL, FIBEROPTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSTLight, Surgical, FiberopticGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061690000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061690000SURGICAL HEADLIGHTGulf Medical Fiberoptics2006-09-15FST

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD32000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Head-worn fibreoptic lightA fibreoptic device mounted on a headband or helmet frame to convey cold light from a connected light source (not included) directly onto the field of vision during a medical or surgical procedure. It typically consists of a magnifying lens, a reflector, and a fibreoptic cable.

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
B382SD491118070Surgical DirectSD49-111807SD49-1118072026-10-22
B382SD77105560Surgical DirectSD77105-56SD77105-562026-10-22
B382SD772553050Surgical DirectSD77255-305SD77255-3052026-10-22
B382SD90120123T0Surgical DirectSD90120123TSD90120123T2026-10-22
B382SD9012101000Surgical DirectSD901210100SD9012101002026-10-22
B382SD901229040Surgical DirectSD90122904SD901229042026-10-22
B382SD9012941000Surgical DirectSD901294100SD9012941002026-10-22
B382SD901294100T0Surgical DirectSD901294100TSD901294100T2026-10-22
B382SD9012981000Surgical DirectSD901298100SD9012981002026-10-22
B382SD901345140Surgical DirectSD90134514SD901345142026-10-22
B382SD901365200Surgical DirectSD90136520SD901365202026-10-22
B382SD9015171000Surgical DirectSD901517100SD9015171002026-10-22
B382SD9015171010Surgical DirectSD901517101SD9015171012026-10-22
B382SD90190030Surgical DirectSD9019003SD90190032026-10-22
B382SD902508010Surgical DirectSD90250801SD902508012026-10-22
B382SD902508030Surgical DirectSD90250803SD902508032026-10-22
B382SD907234170Surgical DirectSD90723417SD907234172026-10-22
B382SD9147211110Surgical DirectSD914721111SD9147211112026-10-22
B382SD9147211120Surgical DirectSD914721112SD9147211122026-10-22
B382SD9147211130Surgical DirectSD914721113SD9147211132026-10-22

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Primary DI, Brand, Company table
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