FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD5657815600
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD56-5781-5-60
Catalog number
SD56-5781-5-60
Device description
60cm 4fr. Ball Tip Flexible Electrode for Flexible Uteroscopes and Cystoscopes
Published
2026-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD5657815600PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, monopolar, reusableAn invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece/housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles); it is not intended for gas-enhanced electrosurgery. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge0
Length0

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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

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Primary DI, Brand, Company table
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07613327688979MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688986MalisSTRYKER CORPORATIONGEI2026-07-29
08800020110688INTRAGen HandpieceJeisys Medical Inc.GEI2026-07-29
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00190776407285MillenniumAvalign Technologies, Inc.GEI2026-07-28
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00198506092954ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092961ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092978ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28