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
B382SD484610Surgical DirectSD48461SD484612026-07-09
B382SD484630Surgical DirectSD48463SD484632026-07-09
B382SD484640Surgical DirectSD48464SD484642026-07-09
B382SD484650Surgical DirectSD48465SD484652026-07-09
B382SD484660Surgical DirectSD48466SD484662026-07-09
B382SD484670Surgical DirectSD48467SD484672026-07-09
B382SD484680Surgical DirectSD48468SD484682026-07-09
B382SD484690Surgical DirectSD48469SD484692026-07-09
B382SD484700Surgical DirectSD48470SD484702026-07-09
B382SD484710Surgical DirectSD48471SD484712026-07-09
B382SD484720Surgical DirectSD48472SD484722026-07-09
B382SD49400B0Surgical DirectSD49400BSD49400B2026-07-09
B382SD49401B0Surgical DirectSD49401BSD49401B2026-07-09
B382SD49402B0Surgical DirectSD49402BSD49402B2026-07-09
B382SD49403B0Surgical DirectSD49403BSD49403B2026-07-09
B382SD49404B0Surgical DirectSD49404BSD49404B2026-07-09
B382SD49405B0Surgical DirectSD49405BSD49405B2026-07-09
B382SD49406B0Surgical DirectSD49406BSD49406B2026-07-09
B382SD49407B0Surgical DirectSD49407BSD49407B2026-07-09
B382SD49408B0Surgical DirectSD49408BSD49408B2026-07-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
B803NL97020200ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020210ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020220ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020230ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020240ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020250ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020260ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020300ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020310ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020320ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020330ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020340ORTHOMEDORTHO-MED, INC.FGN2026-06-23