FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD9190691000
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD919069100
Catalog number
SD919069100
Device description
"16 1/2"" Draffin Bipods Rods"
Published
2025-04-07
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
FGNRETRACTOR, NON-SELF-RETAINING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGNRetractor, Non-Self-RetainingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD9190691000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Mouth gag, non-adjustableA mechanical device without adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral surgical intervention. It is designed to be inserted between the teeth to force the jaws apart and may be in the form of a wedge block, wedge screw, or sprung wedge. Depending on the design it may also be referred to as a jaw spreader, oral wood screw, or mouth prop. 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
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
B382SD907300000Surgical DirectSurgical Direct, Inc.FGN2026-08-21
B382SD91471781220Surgical DirectSurgical Direct, Inc.FGN2026-07-27
B382SD91471781500Surgical DirectSurgical Direct, Inc.FGN2026-07-27
B382SD9141051110Surgical DirectSurgical Direct, Inc.FGN2026-07-24
B382SD155310120Surgical DirectSurgical Direct, Inc.FGN2026-07-23
B382SD155310140Surgical DirectSurgical Direct, Inc.FGN2026-07-23
B382SD1553600Surgical DirectSurgical Direct, Inc.FGN2026-07-23
B382SD9070791100Surgical DirectSurgical Direct, Inc.FGN2026-07-17
B382SD9073531010Surgical DirectSurgical Direct, Inc.FGN2026-07-17
B382SD90738400T0Surgical DirectSurgical Direct, Inc.FGN2026-07-17
B382SD9073931130Surgical DirectSurgical Direct, Inc.FGN2026-07-17
B382SD974411110Surgical DirectSurgical Direct, Inc.FGN2026-07-17
B803NL97020450ORTHOMEDORTHO-MED, INC.FGN2026-06-25
B803COD5045680ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803COD5045690ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803COD5045700ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803COD5045710ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803MA1107210ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803MA1107230ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803MA1107370ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803MA1107390ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803MA1108340ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803MA1108360ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803MA1108370ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020100ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020110ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020120ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020130ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020140ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020150ORTHOMEDORTHO-MED, INC.FGN2026-06-23