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
B382SD9207261140Surgical DirectSD920726114SD9207261142022-12-05
B382SD905500140Surgical DirectSD90550014SD905500142022-11-30
B382SD017210000Surgical DirectSD0172-1000SD0172-10002026-08-21
B382SD13448970Surgical DirectSD13448-97SD13448-972026-08-21
B382SD16008970Surgical DirectSD16008-97SD16008-972026-08-21
B382SD161730Surgical DirectSD1617-3SD1617-32026-08-21
B382SD3028P0Surgical DirectSD3028PSD3028P2026-08-21
B382SD77205052000Surgical DirectSD77205-05-200SD77205-05-2002026-08-21
B382SD77205082000Surgical DirectSD77205-08-200SD77205-08-2002026-08-21
B382SD7720508TS2000Surgical DirectSD77205-08TS-200SD77205-08TS-2002026-08-21
B382SD77205252000Surgical DirectSD77205-25-200SD77205-25-2002026-08-21
B382SD83042110011NS0Surgical DirectSD83042-11001-1NSSD83042-11001-1NS2026-08-21
B382SD9017971000Surgical DirectSD901797100SD9017971002026-08-21
B382SD907300000Surgical DirectSD90730000SD907300002026-08-21
B382SD914775290Surgical DirectSD91477529SD914775292026-08-21
B382SD915039080Surgical DirectSD91503908SD915039082026-08-21
B382SD915039140Surgical DirectSD91503914SD915039142026-08-21
B382SD915039150Surgical DirectSD91503915SD915039152026-08-21
B382SD9227656000Surgical DirectSD922765600SD9227656002026-08-21
B382SD9144941010Surgical DirectSD914494101SD9144941012026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776429102MillenniumAvalign Technologies, Inc.GAD2026-09-04
00840319759400Hayden MedicalHayden Medical, Inc.GAD2026-09-04
00840319759417Hayden MedicalHayden Medical, Inc.GAD2026-09-04
04058749046076NAFehling Instruments GmbH & Co. KGGAD2026-09-04
00190776428129MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428259MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428266MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428273MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428280MillenniumAvalign Technologies, Inc.GAD2026-08-27
00192896123663Meyerding Finger RetractorSONTEC INSTRUMENTS, INC.GAD2026-08-27
00192896123670Meyerding Finger RetractorSONTEC INSTRUMENTS, INC.GAD2026-08-27
00190776423902MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427443MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427450MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427467MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427474MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427481MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427498MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427504MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427511MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427528MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427535MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427658MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427702MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427719MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427726MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427818MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776420291MillenniumAvalign Technologies, Inc.GAD2026-08-25
G453FCE2004SI0PEAK MEDICALPeak Medical Distribution Inc.GAD2026-08-25
G453FCE2005SI0PEAK MEDICALPeak Medical Distribution Inc.GAD2026-08-25