FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD9075041010
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD907504101
Catalog number
SD907504101
Device description
2" Parsonnet Epicardial Retractors, 3 x 3 Prongs
Published
2024-02-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
B382SD9075041010PrimaryHIBCC0

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382S1350010Surgical DirectS1350.01S1350.012026-03-09
B382S18382020Surgical DirectS1838.202S1838.2022026-03-09
B382S18382030Surgical DirectS1838.203S1838.2032026-03-09
B382S18382040Surgical DirectS1838.204S1838.2042026-03-09
B382S18382050Surgical DirectS1838.205S1838.2052026-03-09
B382S18382060Surgical DirectS1838.206S1838.2062026-03-09
B382S18382100Surgical DirectS1838.210S1838.2102026-03-09
B382S18382110Surgical DirectS1838.211S1838.2112026-03-09
B382S18382120Surgical DirectS1838.212S1838.2122026-03-09
B382S2511200Surgical DirectS2511.20S2511.202026-03-09
B382S2548010Surgical DirectS2548.01S2548.012026-03-09
B382S2548020Surgical DirectS2548.02S2548.022026-03-09
B382S2871200Surgical DirectS2871.20S2871.202026-03-09
B382S344901020Surgical DirectS34490.102S34490.1022026-03-09
B382S3797050Surgical DirectS3797.05S3797.052026-03-09
B382S9057001000Surgical DirectS905700.100S905700.1002026-03-09
B382SD18129DK0Surgical DirectSD18129DKSD18129DK2026-03-09
B382SD40060510052E00Surgical DirectSD40060-51005-2ESD40060-51005-2E2026-03-09
B382SD4387110Surgical DirectSD4387-11SD4387-112026-03-09
B382SD481753PTSTR0Surgical DirectSD48-1753PT-STRSD48-1753PT-STR2026-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842102116421Bookler Table Mounted Retractor SystemsFLEXBAR MACHINE CORPORATIONFFO2026-03-19
09348811023667INKAThe Trustee for KAISER FAMILY TRUSTFFO2026-03-16
00192896122765Balfour Deluxe RetractorSONTEC INSTRUMENTS, INC.FFO2026-03-10
B382SD4942000Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942010Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942020Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942030Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942040Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942050Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942060Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942070Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942080Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942090Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942100Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942110Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942120Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942130Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942140Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942150Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942160Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942170Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942180Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942190Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942200Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942210Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD494222Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD494223Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942240Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942250Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942260Surgical DirectSurgical Direct, Inc.FFO2026-03-02