FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD155170E0
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD155170E
Catalog number
SD155170E
Device description
Emmet Hook, Ebonized
Published
2022-11-23
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
B382SD155170E0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Eye muscle hook, reusableA hand-held manual surgical instrument designed to be used to locate and hook extraocular muscles, typically during strabismus correction surgery. It is a slender instrument with a bent blunt distal end and a handle, available in several sizes; some hooks with a very fine shank are designed to allow suture placement behind the hook, providing greater suture security (i.e., better muscle attachment). It is not designed for intraocular use. 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
B382SD9344181000Surgical DirectSD934418100SD9344181002026-07-10
B382SD9344181010Surgical DirectSD934418101SD9344181012026-07-10
B382SD9344181020Surgical DirectSD934418102SD9344181022026-07-10
B382SD9344181030Surgical DirectSD934418103SD9344181032026-07-10
B382SD921226190Surgical DirectSD92122619SD921226192022-12-01
B382SD070823101310Surgical DirectSD07082-31013-1SD07082-31013-12026-09-30
B382SD13768330Surgical DirectSD13768-33SD13768-332026-09-30
B382SD8160490Surgical DirectSD816049SD8160492026-09-30
B382SD90293310010Surgical DirectSD9029331001SD90293310012026-09-30
B382SD907620220Surgical DirectSD90762022SD907620222026-09-30
B382SD9115011000Surgical DirectSD911501100SD9115011002026-09-30
B382SD914800210Surgical DirectSD91480021SD914800212026-09-30
B382SD9156321100Surgical DirectSD915632110SD9156321102026-09-30
B382SD921329100Surgical DirectSD92132910SD921329102026-09-30
B382SD1455810020Surgical DirectSD14558-1002SD14558-10022026-09-29
B382SD1455810030Surgical DirectSD14558-1003SD14558-10032026-09-29
B382SD30550860Surgical DirectSD30550-86SD30550-862026-09-29
B382SD49195170Surgical DirectSD49195-17SD49195-172026-09-29
B382SD4937851340Surgical DirectSD49-3785-134SD49-3785-1342026-09-29
B382SD546210000Surgical DirectSD5462-1000SD5462-10002026-09-29

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