FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD49129070
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD49129-07
Catalog number
SD49129-07
Device description
Tunneler Stainless Steel dissecting tip 7mm
Published
2023-02-22
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
B382SD49129070PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Helicopter ambulanceA helicopter designed (modified and equipped) for use by emergency medical services (EMS) to transport the sick or wounded, especially as a rapid alternative to ground transport around urban areas or during military operations. It will carry onboard equipment for emergency treatment and to maintain or improve the clinical status of the patient, such as devices for carrying or supporting a patient (e.g., stretchers, splints), oxygen therapy (e.g., oxygen cylinders and tubing), intubation/chest decompression (tubes), bleeding control (e.g., bandages, tourniquets), cardioversion/defibrillation (defibrillators), and patient monitoring. It may also carry tools to help extricate a trapped patient.

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382SD89239290Surgical DirectSD8923-929SD8923-9292026-07-17
B382SD89509290Surgical DirectSD8950-929SD8950-9292026-07-17
B382SD89529290Surgical DirectSD8952-929SD8952-9292026-07-17
B382SD89759150Surgical DirectSD8975-915SD8975-9152026-07-17
B382SD89819320Surgical DirectSD8981-932SD8981-9322026-07-17
B382SD89839280Surgical DirectSD8983-928SD8983-9282026-07-17
B382SD89839290Surgical DirectSD8983-929SD8983-9292026-07-17
B382SD89914450Surgical DirectSD8991445SD89914452026-07-17
B382SD9013461020Surgical DirectSD901346102SD9013461022026-07-17
B382SD9070791100Surgical DirectSD907079110SD9070791102026-07-17
B382SD9073531010Surgical DirectSD907353101SD9073531012026-07-17
B382SD90738400T0Surgical DirectSD90738400TSD90738400T2026-07-17
B382SD9073931130Surgical DirectSD907393113SD9073931132026-07-17
B382SD9074751070Surgical DirectSD907475107SD9074751072026-07-17
B382SD9075041030Surgical DirectSD907504103SD9075041032026-07-17
B382SD907505200Surgical DirectSD90750520SD907505202026-07-17
B382SD907505210Surgical DirectSD90750521SD907505212026-07-17
B382SD907530128T0Surgical DirectSD907530128TSD907530128T2026-07-17
B382SD907530129T0Surgical DirectSD907530129TSD907530129T2026-07-17
B382SD907573330Surgical DirectSD90757333SD907573332026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776402112MillenniumAvalign Technologies, Inc.GEN2026-07-19
00190776402136MillenniumAvalign Technologies, Inc.GEN2026-07-19
00190776400255MillenniumAvalign Technologies, Inc.GEN2026-07-17
B382SD9013461020Surgical DirectSurgical Direct, Inc.GEN2026-07-17
00190776397050MillenniumAvalign Technologies, Inc.GEN2026-07-16
00190776398651MillenniumAvalign Technologies, Inc.GEN2026-07-16
B382SD914264010Surgical DirectSurgical Direct, Inc.GEN2026-07-13
00850083275075Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275082Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275099Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275105Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275112Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275129Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275136Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275143Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275280Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275310Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275334Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275358Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275440Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275471Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275495Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275600Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275723Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275846Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275938Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275976Intrace USAPILOTIS TECH LLCGEN2026-07-03
00860015282088Intrace USAPILOTIS TECH LLCGEN2026-07-03
00190776421656MillenniumAvalign Technologies, Inc.GEN2026-06-23
00810055258512Surgical DesignSurgical Design, Inc.GEN2026-06-22