FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD918660100
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD91866010
Catalog number
SD91866010
Device description
6 1/4" Lemole-Strong Aorta Clamp, Bend at Box Lock, Curved Jaw
Published
2026-10-08
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
HTDFORCEPS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD918660100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dressing/utility forceps, scissors-like, reusableA hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

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
B382SD9030741020Surgical DirectSD903074102SD9030741022026-10-08
B382SD907019950Surgical DirectSD90701995SD907019952026-10-08
B382SD9071922050Surgical DirectSD907192205SD9071922052026-10-08
B382SD911160330Surgical DirectSD91116033SD911160332026-10-08
B382SD915039160Surgical DirectSD91503916SD915039162026-10-08
B382SD922616030Surgical DirectSD92261603SD922616032022-12-01
B382SD6713210Surgical DirectSD67-1321SD67-13212026-10-07
B382SD6713290Surgical DirectSD67-1329SD67-13292026-10-07
B382SD9013551000Surgical DirectSD901355100SD9013551002026-10-07
B382SD9013551010Surgical DirectSD901355101SD9013551012026-10-07
B382SD134188100Surgical DirectSD13418-810SD13418-8102026-10-06
B382SD13798330Surgical DirectSD13798-33SD13798-332026-10-06
B382SD6520450Surgical DirectSD65-2045SD65-20452026-10-06
B382SD6562120Surgical DirectSD65-6212SD65-62122026-10-06
B382SD902866230Surgical DirectSD90286623SD902866232026-10-06
B382SD905582180Surgical DirectSD90558218SD905582182026-10-06
B382SD9056791090Surgical DirectSD905679109SD9056791092026-10-06
B382SD9056791170Surgical DirectSD905679117SD9056791172026-10-06
B382SD915598230Surgical DirectSD91559823SD915598232026-10-06
B382SD56534330Surgical DirectSD56534-33SD56534-332025-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776436490MilleniumAvalign Technologies, Inc.HTD2026-10-08
B382SD9071922050Surgical DirectSurgical Direct, Inc.HTD2026-10-08
B382SD9013551000Surgical DirectSurgical Direct, Inc.HTD2026-10-07
B382SD9013551010Surgical DirectSurgical Direct, Inc.HTD2026-10-07
G1415140730Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-10-07
G1415141510Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-10-07
G141514271180Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-10-07
G141549012180Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-10-07
00192896123793Adson Tissue ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-06
00192896123809Micro Skinner ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-06
00192896123823Thumb Dressing ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-06
00192896123830Thumb Dressing ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-06
00192896123847Thumb Dressing ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-06
G141510443190Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G141511368200Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G141511368300Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G14151423610Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G14152810910Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G14154212860Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
00190776432614MillenniumAvalign Technologies, Inc.HTD2026-09-28
00190776432652MillenniumAvalign Technologies, Inc.HTD2026-09-28
00190776432683MillenniumAvalign Technologies, Inc.HTD2026-09-28
00190776432706MillenniumAvalign Technologies, Inc.HTD2026-09-28
00724995323578V. MuellerSTERIS Deutschland GmbHHTD2026-09-25
00724995323585V. MuellerSTERIS Deutschland GmbHHTD2026-09-25
00724995323608V. MuellerSTERIS Deutschland GmbHHTD2026-09-25
00724995323615V. MuellerSTERIS Deutschland GmbHHTD2026-09-25
10886982357298VOLTSynthes GmbHHTD2026-09-25
10886982357304VOLTSynthes GmbHHTD2026-09-25
10886982357311VOLTSynthes GmbHHTD2026-09-25