FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD1449293000
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD144929-300
Catalog number
SD144929-300
Device description
"4 1/2"" Handle for Screwdriver Bit Star, Small Quick Coupling, Black Plastic Handle"
Published
2024-10-22
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
HXXSCREWDRIVER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD1449293000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer 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
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382SD89239290Surgical DirectSD8923-929SD8923-9292026-07-17
B382SD89509290Surgical DirectSD8950-929SD8950-9292026-07-17
B382SD89529290Surgical DirectSD8952-929SD8952-9292026-07-17
B382SD89759150Surgical DirectSD8975-915SD8975-9152026-07-17
B382SD89819320Surgical DirectSD8981-932SD8981-9322026-07-17
B382SD89839280Surgical DirectSD8983-928SD8983-9282026-07-17
B382SD89839290Surgical DirectSD8983-929SD8983-9292026-07-17
B382SD89914450Surgical DirectSD8991445SD89914452026-07-17
B382SD9013461020Surgical DirectSD901346102SD9013461022026-07-17
B382SD9070791100Surgical DirectSD907079110SD9070791102026-07-17
B382SD9073531010Surgical DirectSD907353101SD9073531012026-07-17
B382SD90738400T0Surgical DirectSD90738400TSD90738400T2026-07-17
B382SD9073931130Surgical DirectSD907393113SD9073931132026-07-17
B382SD9074751070Surgical DirectSD907475107SD9074751072026-07-17
B382SD9075041030Surgical DirectSD907504103SD9075041032026-07-17
B382SD907505200Surgical DirectSD90750520SD907505202026-07-17
B382SD907505210Surgical DirectSD90750521SD907505212026-07-17
B382SD907530128T0Surgical DirectSD907530128TSD907530128T2026-07-17
B382SD907530129T0Surgical DirectSD907530129TSD907530129T2026-07-17
B382SD907573330Surgical DirectSD90757333SD907573332026-07-17

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Primary DI, Brand, Company table
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