FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD9190651120
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD919065112
Catalog number
SD919065112
Device description
"Ring Blade for Davis Frame, 7/8"" x 2 1/4"", Right, Size 2, Insulated"
Published
2023-05-31
Public version status
Update
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
B382SD9190651120PrimaryHIBCC0

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(386) 738-1202info@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
B382SD512531140Surgical DirectSD51253114SD512531142026-02-03
B382SD77321140Surgical DirectSD7732114SD77321142026-02-03
B382SD97321140Surgical DirectSD9732114SD97321142026-02-02
B382SD97321150Surgical DirectSD9732115SD97321152026-02-02
B382SD97331160Surgical DirectSD9733116SD97331162026-02-02
B382SD51531140Surgical DirectSD5153114SD51531142025-12-02
B382SD65331140Surgical DirectSD6533114SD65331142025-12-02
B382SD67511170Surgical DirectSD6751117SD67511172025-06-04
B382SD95321140Surgical DirectSD9532114SD95321142025-06-04
B382SD84531130Surgical DirectSD8453113SD84531132025-04-03
B382SD92422150Surgical DirectSD9242215SD92422152025-03-17
B382SD512531150Surgical DirectSD51253115SD512531152025-03-10
B382SD123200Surgical DirectSD12320SD123202024-12-12
B382SD52321110Surgical DirectSD5232111SD52321112024-08-08
B382SD82421110Surgical DirectSD8242111SD82421112024-08-01
B382SD81531140Surgical DirectSD8153114SD81531142024-03-12
B382SD82131160Surgical DirectSD8213116SD82131162024-03-12
B382SD42531170Surgical DirectSD4253117SD42531172024-02-23
B382SD4810450Surgical DirectSD481045SD4810452024-01-31
B382SD77311150Surgical DirectSD7731115SD77311152023-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811019394INKAThe Trustee for KAISER FAMILY TRUSTFGN2025-11-19
09348811019400INKAThe Trustee for KAISER FAMILY TRUSTFGN2025-11-19
07898506814732QuinelatoSchobell Industrial LtdaFGN2023-01-09
10381780268437Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-10-23
10381780268420Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780268499Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269397Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269427Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269489Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269564Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269663Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269670Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269694Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269724Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269748Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269762Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269779Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269816Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780270256Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780268413Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268444Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268451Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268468Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268475Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268482Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268505Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268512Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268529Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268543Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268550Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23