FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD907234170
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD90723417
Catalog number
SD90723417
Device description
7" Obwegeser Ramus Stripper, 11mm Wide
Published
2026-10-22
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
B382SD907234170PrimaryHIBCC0

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
B382SD491118070Surgical DirectSD49-111807SD49-1118072026-10-22
B382SD77105560Surgical DirectSD77105-56SD77105-562026-10-22
B382SD772553050Surgical DirectSD77255-305SD77255-3052026-10-22
B382SD90120123T0Surgical DirectSD90120123TSD90120123T2026-10-22
B382SD9012101000Surgical DirectSD901210100SD9012101002026-10-22
B382SD901229040Surgical DirectSD90122904SD901229042026-10-22
B382SD9012941000Surgical DirectSD901294100SD9012941002026-10-22
B382SD901294100T0Surgical DirectSD901294100TSD901294100T2026-10-22
B382SD9012981000Surgical DirectSD901298100SD9012981002026-10-22
B382SD901345140Surgical DirectSD90134514SD901345142026-10-22
B382SD901365200Surgical DirectSD90136520SD901365202026-10-22
B382SD9015171000Surgical DirectSD901517100SD9015171002026-10-22
B382SD9015171010Surgical DirectSD901517101SD9015171012026-10-22
B382SD90190030Surgical DirectSD9019003SD90190032026-10-22
B382SD902508010Surgical DirectSD90250801SD902508012026-10-22
B382SD902508030Surgical DirectSD90250803SD902508032026-10-22
B382SD9147211110Surgical DirectSD914721111SD9147211112026-10-22
B382SD9147211120Surgical DirectSD914721112SD9147211122026-10-22
B382SD9147211130Surgical DirectSD914721113SD9147211132026-10-22
B382SD483004290Surgical DirectSD48-300429SD48-3004292024-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD48800050Surgical DirectSurgical Direct, Inc.FFO2026-10-15
B382SD717510050Surgical DirectSurgical Direct, Inc.FFO2026-10-15
B382SD1802S90Surgical DirectSurgical Direct, Inc.FFO2026-10-13
B382SD9076011030Surgical DirectSurgical Direct, Inc.FFO2026-10-13
B382SD922616100Surgical DirectSurgical Direct, Inc.FFO2026-10-09
B382SD922616110Surgical DirectSurgical Direct, Inc.FFO2026-10-09
B382SD907620220Surgical DirectSurgical Direct, Inc.FFO2026-09-30
B382SD9076671330Surgical DirectSurgical Direct, Inc.FFO2026-09-29
B382SD914180130Surgical DirectSurgical Direct, Inc.FFO2026-09-29
00810238290049PRINCETONPrinceton Medical Group, Inc.FFO2026-09-22
00850088713862PRINCETONPrinceton Medical Group, Inc.FFO2026-09-22
04049047074694GimmiGimmi GmbHFFO2026-08-14
B382SD921405170Surgical DirectSurgical Direct, Inc.FFO2026-08-07
B382SD93415040Surgical DirectSurgical Direct, Inc.FFO2026-08-07
B382SD459000Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD460350Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD460360Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467000Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467010Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467020Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467030Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467040Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467050Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD48250Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD493680Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD493690Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD493770Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD6213120Surgical DirectSurgical Direct, Inc.FFO2026-08-03
00190776407483MillenniumAvalign Technologies, Inc.FFO2026-07-31
B382SD14174550Surgical DirectSurgical Direct, Inc.FFO2026-07-31