FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD276590
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD27659
Catalog number
SD27659
Device description
3mm Biopsy Cup Forcep, Straight
Published
2020-04-28
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
KFTAssembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KFTAssembly, Shoulder/Elbow/Forearm/Wrist/Hand, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD276590PrimaryHIBCC0

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter3Millimeter

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
B382SD13108150Surgical DirectSD13108-15SD13108-152026-10-30
B382SD15908450Surgical DirectSD 1590845SD 15908452026-10-30
B382SD32154290Surgical DirectSD3215429SD32154292026-10-30
B382SD902405100Surgical DirectSD90240510SD902405102026-10-30
B382SD914178350Surgical DirectSD91417835SD914178352026-10-30
B382SD9144841120Surgical DirectSD914484112SD9144841122026-10-30
B382SD9144841140Surgical DirectSD914484114SD9144841142026-10-30
B382SD9144841250Surgical DirectSD914484125SD9144841252026-10-30
B382SD9144842000Surgical DirectSD914484200SD9144842002026-10-30
B382SD9144842010Surgical DirectSD914484201SD9144842012026-10-30
B382SD9144842020Surgical DirectSD914484202SD9144842022026-10-30
B382SD9144842030Surgical DirectSD914484203SD9144842032026-10-30
B382SD9144842040Surgical DirectSD914484204SD9144842042026-10-30
B382SD9144843000Surgical DirectSD914484300SD9144843002026-10-30
B382SD9144843010Surgical DirectSD914484301SD9144843012026-10-30
B382SD9144843020Surgical DirectSD914484302SD9144843022026-10-30
B382SD9144843030Surgical DirectSD914484303SD9144843032026-10-30
B382SD9144843040Surgical DirectSD914484304SD9144843042026-10-30
B382SD914763020Surgical DirectSD91476302SD914763022026-10-30
B382SD915584140Surgical DirectSD91558414SD915584142026-10-30