FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD9147091150
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD914709115
Catalog number
SD914709115
Device description
10" Woodson Elevator and Spatula, Double Ended, 3.0mm - 4.0mm
Published
2026-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEGElevator, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEGElevator, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD9147091150PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone lever/elevator, reusableA manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382SD13517450Surgical DirectSD 1351745SD 13517452026-10-28
B382SD13518130Surgical DirectSD13518-13SD13518-132026-10-28
B382SD15908130Surgical DirectSD15908-13SD15908-132026-10-28
B382SD161310590Surgical DirectSD16131059SD161310592026-10-28
B382SD48310090Surgical DirectSD48-31009SD48-310092026-10-28
B382SD4865700Surgical DirectSD48-6570SD48-65702026-10-28
B382SD6200420Surgical DirectSD62-0042SD62-00422026-10-28
B382SD6200430Surgical DirectSD62-0043SD62-00432026-10-28
B382SD62372600Surgical DirectSD62-37260SD62-372602026-10-28
B382SD62372610Surgical DirectSD62-37261SD62-372612026-10-28
B382SD62372620Surgical DirectSD62-37262SD62-372622026-10-28
B382SD62372700Surgical DirectSD62-37270SD62-372702026-10-28
B382SD62372710Surgical DirectSD62-37271SD62-372712026-10-28
B382SD62372720Surgical DirectSD62-37272SD62-372722026-10-28
B382SD62373320Surgical DirectSD62-37332SD62-373322026-10-28
B382SD62373340Surgical DirectSD62-37334SD62-373342026-10-28
B382SD62373360Surgical DirectSD62-37336SD62-373362026-10-28
B382SD67371410Surgical DirectSD67-37141SD67-371412026-10-28
B382SD6787200Surgical DirectSD67-8720SD67-87202026-10-28
B382SD77505940Surgical DirectSD77505-94SD77505-942026-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250337117919Elevator, smallJoimax GmbHGEG2026-10-27
04250337119623NiTi Nerve Hook, superelasticJoimax GmbHGEG2026-10-27
04250337122043ElevatorJoimax GmbHGEG2026-10-27
00190776435738MillenniumAvalign Technologies, Inc.GEG2026-10-21
00190776435486MillenniumAvalign Technologies, Inc.GEG2026-10-20
00190776435141MillenniumAvalign Technologies, Inc.GEG2026-10-16
00190776435202MillenniumAvalign Technologies, Inc.GEG2026-10-16
00724995268053Snowden-PencerSTERIS Deutschland GmbHGEG2026-10-15
00724995268060Snowden-PencerSTERIS Deutschland GmbHGEG2026-10-15
B382SD914700200Surgical DirectSurgical Direct, Inc.GEG2026-10-09
B382SD922682100Surgical DirectSurgical Direct, Inc.GEG2026-10-09
B382SD939422110Surgical DirectSurgical Direct, Inc.GEG2026-10-09
B382SD907019950Surgical DirectSurgical Direct, Inc.GEG2026-10-08
00190776433567MillenniumAvalign Technologies, Inc.GEG2026-10-06
00190776433574MillenniumAvalign Technologies, Inc.GEG2026-10-06
00190776433253MillenniumAvalign Technologies, Inc.GEG2026-10-05
00190776433260MillenniumAvalign Technologies, Inc.GEG2026-10-05
00190776433277MillenniumAvalign Technologies, Inc.GEG2026-10-05
B382SD9071741090Surgical DirectSurgical Direct, Inc.GEG2026-09-29
B382SD9207121110Surgical DirectSurgical Direct, Inc.GEG2026-09-29
00724995267995Snowden-PencerSTERIS Deutschland GmbHGEG2026-09-25
00724995268008Snowden-PencerSTERIS Deutschland GmbHGEG2026-09-25
00724995268015Snowden-PencerSTERIS Deutschland GmbHGEG2026-09-25
00724995268022Snowden-PencerSTERIS Deutschland GmbHGEG2026-09-25
00724995268039Snowden-PencerSTERIS Deutschland GmbHGEG2026-09-25
00724995268046Snowden-PencerSTERIS Deutschland GmbHGEG2026-09-25
00190776431600MillenniumAvalign Technologies, Inc.GEG2026-09-22
00190776424091MillenniumAvalign Technologies, Inc.GEG2026-08-27
00190776428297MillenniumAvalign Technologies, Inc.GEG2026-08-27
00190776427733MillenniumAvalign Technologies, Inc.GEG2026-08-26