FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD5731126E0
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD57-311-26-E
Catalog number
SD57-311-26-E
Device description
"10"" Schroeder Tenaculum Forceps, Single Tooth Pointed, Pozzi Style, Round Insulated Tip, Ebonized"
Published
2023-07-14
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
HTDForceps

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD5731126E0PrimaryHIBCC0

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(386) 738-1202info@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
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
10886982357328VOLTSynthes GmbHHTD2026-09-25
10886982357854VOLTSynthes GmbHHTD2026-09-25
10886982357861VOLTSynthes GmbHHTD2026-09-25
10886982357878VOLTSynthes GmbHHTD2026-09-25
10886982357885VOLTSynthes GmbHHTD2026-09-25
00810238290063PRINCETONPrinceton Medical Group, Inc.HTD2026-09-22
00810238290087PRINCETONPrinceton Medical Group, Inc.HTD2026-09-22
00850088713916PRINCETONPrinceton Medical Group, Inc.HTD2026-09-22
00850088713930PRINCETONPrinceton Medical Group, Inc.HTD2026-09-22
00850088713947PRINCETONPrinceton Medical Group, Inc.HTD2026-09-22
00190776431082MillenniumAvalign Technologies, Inc.HTD2026-09-21
00190776430962MillenniumAvalign Technologies, Inc.HTD2026-09-18
00192896123755Debakey-Diethrich Tissue ForcepsSONTEC INSTRUMENTS, INC.HTD2026-09-18