FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD9152181060
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD915218106
Catalog number
SD915218106
Device description
8' Caspar Vertebral Body Dissector, Angled, Flat Tip, with Stainless Steel Handle
Published
2026-11-03
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
GDIDissector, Surgical, General & Plastic Surgery

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD9152181060PrimaryHIBCC0

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
B382SD402590Surgical DirectSD40259SD402592026-11-03
B382SD429490Surgical DirectSD42949SD429492026-11-03
B382SD62031510Surgical DirectSD62-031-51SD62-031-512026-11-04
B382SD89259100Surgical DirectSD8925-910SD8925-9102026-11-03
B382SD89519020Surgical DirectSD8951-902SD8951-9022026-11-03
B382SD902171200Surgical DirectSD90217120SD902171202026-11-04
B382SD9146531600Surgical DirectSD914653160SD9146531602026-11-04
B382SD9146531620Surgical DirectSD914653162SD9146531622026-11-04
B382SD9146531630Surgical DirectSD914653163SD9146531632026-11-04
B382SD9146531640Surgical DirectSD914653164SD9146531642026-11-04
B382SD9152181070Surgical DirectSD915218107SD9152181072026-11-03
B382SD9180201110Surgical DirectSD918020111SD9180201112026-11-04
B382SD921171120Surgical DirectSD92117112SD921171122026-11-03
B382SD921171190Surgical DirectSD92117119SD921171192026-11-03
B382SD922864110Surgical DirectSD92286411SD922864112026-11-03
B382SD922864120Surgical DirectSD92286412SD922864122026-11-03
B382SD922864130Surgical DirectSD92286413SD922864132026-11-03
B382SD9233161140Surgical DirectSD923316114SD9233161142026-11-03
B382SD9340311010Surgical DirectSD934031101SD9340311012026-11-03
B382SD934444110Surgical DirectSD93444411SD934444112026-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD9152181070Surgical DirectSurgical Direct, Inc.GDI2026-11-03
00850090726201Intrace USAPILOTIS TECH LLCGDI2026-10-31
00190776435363MillenniumAvalign Technologies, Inc.GDI2026-10-19
00190776433765MillenniumAvalign Technologies, Inc.GDI2026-10-08
00190776433758MillenniumAvalign Technologies, Inc.GDI2026-10-07
G141530254210Carnegie Surgical LLCCarnegie Surgical LLCGDI2026-10-07
G14155805410Carnegie Surgical LLCCarnegie Surgical LLCGDI2026-10-07
G14155805420Carnegie Surgical LLCCarnegie Surgical LLCGDI2026-10-07
G14167216050Carnegie Surgical LLCCarnegie Surgical LLCGDI2026-10-07
G1415530254210Carnegie Surgical LLCCarnegie Surgical LLCGDI2026-09-30
00190776432461MillenniumAvalign Technologies, Inc.GDI2026-09-24
G4533310930PEAK MEDICALPeak Medical Distribution Inc.GDI2026-08-27
00190776419110MillenniumAvalign Technologies, Inc.GDI2026-08-23
00840217910286Wiggins MedicalEBNER MEDICAL, LLCGDI2026-08-13
00190776424367MillenniumAvalign Technologies, Inc.GDI2026-08-07
00190776408626MillenniumAvalign Technologies, Inc.GDI2026-08-03
B382SD914709040Surgical DirectSurgical Direct, Inc.GDI2026-07-29
00810068850765Biocore9 Acetabular Bearing SystemBiocore9, LLCGDI2026-06-26
07898789390121ENDOFOREHEAD DISSECTOR 5MM ANGLEDTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-06-09
07898789390138ENDOFOREHEAD DISSECTOR WITH SUCTION STRAIGHT 30CMTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-06-09
07898789390039GRAIVIER MID-FACE DISSECTOR LEFTTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
07898789390046GRAIVIER MID-FACE DISSECTOR RIGHTTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
07898789390060FRONTO MARTINS 2 ENDOFOREHEAD DISSECTORTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
00196449034512Anatomic Access LLIFTyber Medical, LLCGDI2025-10-22
00840217909570Wiggins MedicalEBNER MEDICAL, LLCGDI2025-04-08
00840217909587Wiggins MedicalEBNER MEDICAL, LLCGDI2025-04-08
00840217909358Ace Medical CompanyEBNER MEDICAL, LLCGDI2024-12-09
00840217909365Ace Medical CompanyEBNER MEDICAL, LLCGDI2024-12-09
00840217909372Ace Medical CompanyEBNER MEDICAL, LLCGDI2024-12-09
00840217909389Ace Medical CompanyEBNER MEDICAL, LLCGDI2024-12-09