FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD2000350
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD200-035
Catalog number
SD200-035
Device description
Sterilization Case With Silicone Mat, 11''L x 7''W x 1 1/2''H
Published
2023-05-18
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
GENForceps, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD2000350PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization container matA non-sterile soft polymer sheet intended to be placed within a container/tray used for instrument sterilization, to protect and help facilitate complete sterilization of the underside of instruments. It is in the form of a textured sheet, typically with flexible polymer pins designed to reduce instrument/surface contact. This is a reusable device.

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
B382S2752108T0Surgical DirectS2752.108TS2752.108T2026-08-03
B382SD20260Surgical DirectSD2-026SD2-0262026-08-03
B382SD319590Surgical DirectSD31959SD319592026-08-03
B382SD32153690Surgical DirectSD3215369SD32153692026-08-03
B382SD346130Surgical DirectSD34613SD346132026-08-03
B382SD350110Surgical DirectSD914709148SD9147091482026-08-03
B382SD38060Surgical DirectSD3806SD38062026-08-03
B382SD4121490Surgical DirectSD412149SD4121492026-08-03
B382SD4131490Surgical DirectSD413149SD4131492026-08-03
B382SD4162910Surgical DirectSD416291SD4162912026-08-03
B382SD4319D0Surgical DirectSD4319DSD4319D2026-08-03
B382SD439190Surgical DirectSD43919SD439192026-08-03
B382SD441309197120Surgical DirectSD4413-0919712SD4413-09197122026-08-03
B382SD45267180Surgical DirectSD45-26718SD45-267182026-08-03
B382SD459000Surgical DirectSD45900SD459002026-08-03
B382SD460350Surgical DirectSD46035SD460352026-08-03
B382SD460360Surgical DirectSD46036SD460362026-08-03
B382SD467000Surgical DirectSD46700SD467002026-08-03
B382SD467010Surgical DirectSD46701SD467012026-08-03
B382SD467020Surgical DirectSD46702SD467022026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776408763MillenniumAvalign Technologies, Inc.GEN2026-08-03
00190776422721MillenniumAvalign Technologies, Inc.GEN2026-08-03
00190776422769MillenniumAvalign Technologies, Inc.GEN2026-08-03
00190776422790MillenniumAvalign Technologies, Inc.GEN2026-08-03
B382SD4829170Surgical DirectSurgical Direct, Inc.GEN2026-08-03
00190776422141MillenniumAvalign Technologies, Inc.GEN2026-07-31
00190776422226MillenniumAvalign Technologies, Inc.GEN2026-07-31
00190776422233MillenniumAvalign Technologies, Inc.GEN2026-07-31
B382SD1426525010Surgical DirectSurgical Direct, Inc.GEN2026-07-31
B382SD1426525020Surgical DirectSurgical Direct, Inc.GEN2026-07-31
00810143904840SURGIPROSSurgipros, LLCGEN2026-07-30
00810143904857SURGIPROSSurgipros, LLCGEN2026-07-30
00810143904864SURGIPROSSurgipros, LLCGEN2026-07-30
00810143909227SURGIPROSSurgipros, LLCGEN2026-07-30
00810143909715SURGIPROSSurgipros, LLCGEN2026-07-30
00810143909746SURGIPROSSurgipros, LLCGEN2026-07-30
00810212934860SURGIPROSSurgipros, LLCGEN2026-07-30
00810212934877SURGIPROSSurgipros, LLCGEN2026-07-30
00810212934884SURGIPROSSurgipros, LLCGEN2026-07-30
00810212934891SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935362SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935379SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935546SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935553SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935560SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935584SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935591SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935669SURGIPROSSurgipros, LLCGEN2026-07-30
B382SD919327220Surgical DirectSurgical Direct, Inc.GEN2026-07-29
B382SD919327230Surgical DirectSurgical Direct, Inc.GEN2026-07-29