FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD983510
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD98351
Catalog number
SD98351
Device description
5mm 33cm Flat Blunt Dissector, Fenestrated, Original Locking Handle
Published
2020-04-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K914910000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914910000DAVOL LAPAROSCOPIC INSTRUMENTS (GEN SURG REUSABLE)Davol, Inc.1992-01-06GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD983510PrimaryHIBCC0

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length33Centimeter
Outer Diameter5Millimeter

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382SD402590Surgical DirectSD40259SD402592026-11-03
B382SD429490Surgical DirectSD42949SD429492026-11-03
B382SD62031510Surgical DirectSD62-031-51SD62-031-512026-11-04
B382SD89259100Surgical DirectSD8925-910SD8925-9102026-11-03
B382SD89519020Surgical DirectSD8951-902SD8951-9022026-11-03
B382SD902171200Surgical DirectSD90217120SD902171202026-11-04
B382SD9146531600Surgical DirectSD914653160SD9146531602026-11-04
B382SD9146531620Surgical DirectSD914653162SD9146531622026-11-04
B382SD9146531630Surgical DirectSD914653163SD9146531632026-11-04
B382SD9146531640Surgical DirectSD914653164SD9146531642026-11-04
B382SD9152181060Surgical DirectSD915218106SD9152181062026-11-03
B382SD9152181070Surgical DirectSD915218107SD9152181072026-11-03
B382SD9180201110Surgical DirectSD918020111SD9180201112026-11-04
B382SD921171120Surgical DirectSD92117112SD921171122026-11-03
B382SD921171190Surgical DirectSD92117119SD921171192026-11-03
B382SD922864110Surgical DirectSD92286411SD922864112026-11-03
B382SD922864120Surgical DirectSD92286412SD922864122026-11-03
B382SD922864130Surgical DirectSD92286413SD922864132026-11-03
B382SD9233161140Surgical DirectSD923316114SD9233161142026-11-03
B382SD9340311010Surgical DirectSD934031101SD9340311012026-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776437602MillenniumAvalign Technologies, Inc.GEI2026-11-04
B382SD89259100Surgical DirectSurgical Direct, Inc.GEI2026-11-03
B382SD89519020Surgical DirectSurgical Direct, Inc.GEI2026-11-03
SD89839030Surgical DirectSurgical Direct, Inc.GEI2026-11-03
03830066950271GREEN IRFIskra Medical, d.o.o.GEI2026-11-02
00199150071999MedtronicMEDTRONIC NAVIGATION, INC.GEI2026-11-01
00810026184093Bipolar ForcepsSONIQUENCE, LLCGEI2026-11-01
00841019124147KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-31
04953170467875THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-29
04953170467882THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-29
00841019124178KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-28
00841019124161KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-27
00841019124239KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-27
00190776439774MilleniumAvalign Technologies, Inc.GEI2026-10-26
10884521783829LigaSureCovidien LPGEI2026-10-23
00190776436858MillenniumAvalign Technologies, Inc.GEI2026-10-22
B382SD77105560Surgical DirectSurgical Direct, Inc.GEI2026-10-22
00190776435752MillenniumAvalign Technologies, Inc.GEI2026-10-21
00190776435769MillenniumAvalign Technologies, Inc.GEI2026-10-21
00841019124192KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-21
B108499AP1MRA1MUS00Large applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA2MUS00Small applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA45MUS00Edge applicatorsBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499PO1MUS00BTL-499-1BTL INDUSTRIES LIMITEDGEI2026-10-20
00190776435288MillenniumAvalign Technologies, Inc.GEI2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19