FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD49129120
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD49129-12
Catalog number
SD49129-12
Device description
Tunneler Stainless Steel Dissecting Tip 12mm
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
B382SD49129120PrimaryHIBCC0

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
B382SD482012L0Surgical DirectSD48-2012LSD48-2012L2025-10-06
B382SD23170Surgical DirectSD2317SD23172026-10-15
B382SD25090Surgical DirectSD2509SD25092026-10-15
B382SD379410Surgical DirectSD37941SD379412026-10-15
B382SD4830070Surgical DirectSD48-3007SD48-30072026-10-15
B382SD4840320Surgical DirectSD48-4032SD48-40322026-10-15
B382SD48800050Surgical DirectSD48-80005SD48-800052026-10-15
B382SD491118030Surgical DirectSD49-111803SD49-1118032026-08-04
B382SD62371520Surgical DirectSD62-37152SD62-371522026-10-15
B382SD717510050Surgical DirectSD7175-1005SD7175-10052026-10-15
B382SD9025151020Surgical DirectSD902515102SD9025151022026-10-15
B382SD903223060Surgical DirectSD90322306SD903223062026-10-15
B382SD903454040Surgical DirectSD90345404SD903454042026-10-15
B382SD903454060Surgical DirectSD90345406SD903454062026-10-15
B382SD911434070Surgical DirectSD91143407SD911434072026-10-15
B382SD914174550Surgical DirectSD91417455SD914174552026-10-15
B382SD9141781090Surgical DirectSD914178109SD9141781092026-10-15
B382SD9141781620Surgical DirectSD914178162SD9141781622026-10-15
B382SD914603200Surgical DirectSD91460320SD914603202026-10-15
B382SD920761000Surgical DirectSD92076100SD920761002026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435448MillenniumAvalign Technologies, Inc.GEN2026-10-19
00840329838669N/ABLACK & BLACK SURGICAL, INC.GEN2026-10-15
00190776435011MillenniumAvalign Technologies, Inc.GEN2026-10-14
00190776435035MillenniumAvalign Technologies, Inc.GEN2026-10-14
00190776434816MillenniumAvalign Technologies, Inc.GEN2026-10-13
00190776434779MillenniumAvalign Technologies, Inc.GEN2026-10-12
04058749012842NAFehling Instruments GmbH & Co. KGGEN2026-10-12
00190776434175MillenniumAvalign Technologies, Inc.GEN2026-10-09
00198506095801ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00198506095818ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00198506095825ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00198506095832ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00840314252449gSourceGSOURCE LLCGEN2026-10-09
00190776436605MilleniumAvalign Technologies, Inc.GEN2026-10-08
00190776433604MillenniumAvalign Technologies, Inc.GEN2026-10-07
00190776434380MillenniumAvalign Technologies, Inc.GEN2026-10-07
B382SD6713210Surgical DirectSurgical Direct, Inc.GEN2026-10-07
B382SD6713290Surgical DirectSurgical Direct, Inc.GEN2026-10-07
B382SD6520450Surgical DirectSurgical Direct, Inc.GEN2026-10-06
B382SD6562120Surgical DirectSurgical Direct, Inc.GEN2026-10-06
00190776433048MillenniumAvalign Technologies, Inc.GEN2026-10-01
00190776433130MillenniumAvalign Technologies, Inc.GEN2026-10-01
00190776433147MillenniumAvalign Technologies, Inc.GEN2026-10-01
00190776433178MillenniumAvalign Technologies, Inc.GEN2026-10-01
B382SD8160490Surgical DirectSurgical Direct, Inc.GEN2026-09-30
00190776432829MillenniumAvalign Technologies, Inc.GEN2026-09-29
00190776432898MillenniumAvalign Technologies, Inc.GEN2026-09-29
B382SD4937851340Surgical DirectSurgical Direct, Inc.GEN2026-09-29
00190776432522MillenniumAvalign Technologies, Inc.GEN2026-09-28
00190776432553MillenniumAvalign Technologies, Inc.GEN2026-09-28