FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD907581320
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD90758132
Catalog number
SD90758132
Device description
5 1/2" Deep Gelpi Retractor, 65mm Drop, Crossing Closed Tips
Published
2026-07-24
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
B382SD907581320PrimaryHIBCC0

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
B382SD902511300Surgical DirectSD90251130SD902511302026-07-24
B382SD907394200Surgical DirectSD90739420SD907394202026-07-24
B382SD9141051110Surgical DirectSD914105111SD9141051112026-07-24
B382SD9141071020Surgical DirectSD914107102SD9141071022026-07-24
B382SD9141071030Surgical DirectSD914107103SD9141071032026-07-24
B382SD9141071040Surgical DirectSD914107104SD9141071042026-07-24
B382SD9141551000Surgical DirectSD914155100SD9141551002026-07-24
B382SD914172160Surgical DirectSD91417216SD914172162026-07-24
B382SD9141731000Surgical DirectSD914173100SD9141731002026-07-24
B382SD9141781300Surgical DirectSD914178130SD9141781302026-07-24
B382SD306090Surgical DirectSD30609SD306092022-11-23
B382SD155310120Surgical DirectSD15531012SD155310122026-07-23
B382SD155310140Surgical DirectSD15531014SD155310142026-07-23
B382SD1553600Surgical DirectSD155360SD1553602026-07-23
B382SD9017971040Surgical DirectSD901797104SD9017971042026-07-23
B382SD9029931060Surgical DirectSD902993106SD9029931062026-07-23
B382SD905701100Surgical DirectSD90570110SD905701102026-07-23
B382SD9114061030Surgical DirectSD911406103SD9114061032026-07-23
B382SD911424030Surgical DirectSD91142403SD911424032026-07-23
B382SD911424050Surgical DirectSD91142405SD911424052026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD9075041030Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907530128T0Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907530129T0Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907573330Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD9075800910Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907580150Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD9076231100Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD77550140Surgical DirectSurgical Direct, Inc.FFO2026-07-14
B382SD918174150Surgical DirectSurgical Direct, Inc.FFO2026-07-13
B382SD9183701030Surgical DirectSurgical Direct, Inc.FFO2026-07-13
B382SD484610Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484630Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484640Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484650Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484660Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484670Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484680Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484690Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484700Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484710Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484720Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD9147091620Surgical DirectSurgical Direct, Inc.FFO2026-07-09
09348811114068INKAThe Trustee for KAISER FAMILY TRUSTFFO2026-05-29
09348811114075INKAThe Trustee for KAISER FAMILY TRUSTFFO2026-05-29
B382SD915097010Surgical DirectSurgical Direct, Inc.FFO2026-02-09
09348811023612INKAThe Trustee for KAISER FAMILY TRUSTFFO2025-11-19
00899054002661Valve Assist Blade, Reusable, Stainless Steel, 11mm x 26mmKDL Medical, Inc.FFO2025-02-10
00899054002678Valve Assist Blade, Reusable, Stainless Steel, 15mm x 26mmKDL Medical, Inc.FFO2025-02-10
00899054002685Valve Assist Blade, Reusable, Stainless Steel, 18mm x 26mmKDL Medical, Inc.FFO2025-02-10
00899054002692Atrial Rake, Reusable, Stainless Steel, 19mm x 24mmKDL Medical, Inc.FFO2025-02-10