FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD484600
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD48460
Catalog number
SD48460
Device description
Caspar Cervical Retractor Handle for Blade Positioning
Published
2026-08-07
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
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD484600PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

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
B382SD484620Surgical DirectSD48462SD484622026-08-07
B382SD902508070Surgical DirectSD90250807SD902508072026-08-07
B382SD902509010Surgical DirectSD90250901SD902509012026-08-07
B382SD9025181000Surgical DirectSD902518100SD9025181002026-08-07
B382SD9028531640Surgical DirectSD902853164SD9028531642026-08-07
B382SD9032161050Surgical DirectSD903216105SD9032161052026-08-07
B382SD9032191040Surgical DirectSD903219104SD9032191042026-08-07
B382SD9032191050Surgical DirectSD903219105SD9032191052026-08-07
B382SD9034951000Surgical DirectSD903495100SD9034951002026-08-07
B382SD9034951010Surgical DirectSD903495101SD9034951012026-08-07
B382SD9037751020Surgical DirectSD903775102SD9037751022026-08-07
B382SD903797050Surgical DirectSD90379705SD903797052026-08-07
B382SD9213571010Surgical DirectSD921483109SD9214831092026-08-07
B382SD9213571070Surgical DirectSD921357107SD9213571072026-08-07
B382SD9213711000Surgical DirectSD921396115SD9213961152026-08-07
B382SD9213711010Surgical DirectSD921371101SD9213711012026-08-07
B382SD921377200Surgical DirectSD92137720SD921377202026-08-07
B382SD921381030Surgical DirectSD92138103SD921381032026-08-07
B382SD9213821020Surgical DirectSD921382102SD9213821022026-08-07
B382SD921405170Surgical DirectSD92140517SD921405172026-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776423551MillenniumAvalign Technologies, Inc.GAD2026-08-07
00190776423742MillenniumAvalign Technologies, Inc.GAD2026-08-07
00190776423759MillenniumAvalign Technologies, Inc.GAD2026-08-07
00190776423766MillenniumAvalign Technologies, Inc.GAD2026-08-07
00190776423773MillenniumAvalign Technologies, Inc.GAD2026-08-07
00190776423780MillenniumAvalign Technologies, Inc.GAD2026-08-07
00190776424411MillenniumAvalign Technologies, Inc.GAD2026-08-07
00190776424428MillenniumAvalign Technologies, Inc.GAD2026-08-07
00190776424442MillenniumAvalign Technologies, Inc.GAD2026-08-07
00190776424480MillenniumAvalign Technologies, Inc.GAD2026-08-07
G4533315010BC0PEAK MEDICALPeak Medical Distribution Inc.GAD2026-08-07
G4533315012BC0PEAK MEDICALPeak Medical Distribution Inc.GAD2026-08-07
00190776422615MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422691MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422707MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422714MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422776MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422882MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422905MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422264MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422288MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422301MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422530MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422547MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422554MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422561MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422578MillenniumAvalign Technologies, Inc.GAD2026-07-31
B382S349571000Surgical DirectSurgical Direct, Inc.GAD2026-07-31
00199150083107Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-07-30
00199150083879Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-07-30