FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD124421000
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD12442-100
Catalog number
SD12442-100
Device description
"Tebbets Style Fiberoptic Retractor, 1 1/4"" x 8"" Blade, with Flat Smooth Tip with Suction, Gold Plated Handle"
Published
2026-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFORETRACTOR, SELF-RETAINING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFORetractor, Self-RetainingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD124421000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Self-retaining surgical retractor, reusableA hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382SD134188100Surgical DirectSD13418-810SD13418-8102026-10-06
B382SD13798330Surgical DirectSD13798-33SD13798-332026-10-06
B382SD6520450Surgical DirectSD65-2045SD65-20452026-10-06
B382SD6562120Surgical DirectSD65-6212SD65-62122026-10-06
B382SD902866230Surgical DirectSD90286623SD902866232026-10-06
B382SD905582180Surgical DirectSD90558218SD905582182026-10-06
B382SD9056791090Surgical DirectSD905679109SD9056791092026-10-06
B382SD9056791170Surgical DirectSD905679117SD9056791172026-10-06
B382SD915598230Surgical DirectSD91559823SD915598232026-10-06
B382SD56534330Surgical DirectSD56534-33SD56534-332025-09-10
B382SD4830050Surgical DirectSD48-3005SD48-30052025-12-08
B382SD9141792000Surgical DirectSD914179200SD9141792002024-06-24
B382SD907186100Surgical DirectSD90718610SD907186102023-04-24
B382SD934496030Surgical DirectSD93449603SD934496032023-02-22
B382SD917665010Surgical DirectSD91766501SD917665012022-12-01
B382SD934496020Surgical DirectSD93449602SD934496022022-12-01
B382SD1618230Surgical DirectSD161823SD1618232022-11-23
B382SD161824530Surgical DirectSD16182453SD161824532022-11-23
B382SD413690Surgical DirectSD41369SD413692020-04-27
B382SD232590Surgical DirectSD23259SD232592020-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD907620220Surgical DirectSurgical Direct, Inc.FFO2026-09-30
B382SD9076671330Surgical DirectSurgical Direct, Inc.FFO2026-09-29
B382SD914180130Surgical DirectSurgical Direct, Inc.FFO2026-09-29
00810238290049PRINCETONPrinceton Medical Group, Inc.FFO2026-09-22
00850088713862PRINCETONPrinceton Medical Group, Inc.FFO2026-09-22
04049047074694GimmiGimmi GmbHFFO2026-08-14
B382SD921405170Surgical DirectSurgical Direct, Inc.FFO2026-08-07
B382SD93415040Surgical DirectSurgical Direct, Inc.FFO2026-08-07
B382SD459000Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD460350Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD460360Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467000Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467010Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467020Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467030Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467040Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467050Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD48250Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD493680Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD493690Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD493770Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD6213120Surgical DirectSurgical Direct, Inc.FFO2026-08-03
00190776407483MillenniumAvalign Technologies, Inc.FFO2026-07-31
B382SD14174550Surgical DirectSurgical Direct, Inc.FFO2026-07-31
B382SD90712216T0Surgical DirectSurgical Direct, Inc.FFO2026-07-29
B382SD907581320Surgical DirectSurgical Direct, Inc.FFO2026-07-24
B382SD9075041030Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907530128T0Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907530129T0Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907573330Surgical DirectSurgical Direct, Inc.FFO2026-07-17