FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD7720520001
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD77205-200-01
Catalog number
SD77205-200-01
Device description
5mm 32cm Scissor Style Kleppinger Bipolar Forceps, Shaft and Handle Only
Published
2026-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
B382SD7720520001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, bipolar, reusableAn invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It is 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 or housing and has no electrical or mechanical controls (e.g., does not include ring-handles). This is a reusable device.

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
B382SD13517450Surgical DirectSD 1351745SD 13517452026-10-28
B382SD13518130Surgical DirectSD13518-13SD13518-132026-10-28
B382SD15908130Surgical DirectSD15908-13SD15908-132026-10-28
B382SD161310590Surgical DirectSD16131059SD161310592026-10-28
B382SD48310090Surgical DirectSD48-31009SD48-310092026-10-28
B382SD4865700Surgical DirectSD48-6570SD48-65702026-10-28
B382SD6200420Surgical DirectSD62-0042SD62-00422026-10-28
B382SD6200430Surgical DirectSD62-0043SD62-00432026-10-28
B382SD62372600Surgical DirectSD62-37260SD62-372602026-10-28
B382SD62372610Surgical DirectSD62-37261SD62-372612026-10-28
B382SD62372620Surgical DirectSD62-37262SD62-372622026-10-28
B382SD62372700Surgical DirectSD62-37270SD62-372702026-10-28
B382SD62372710Surgical DirectSD62-37271SD62-372712026-10-28
B382SD62372720Surgical DirectSD62-37272SD62-372722026-10-28
B382SD62373320Surgical DirectSD62-37332SD62-373322026-10-28
B382SD62373340Surgical DirectSD62-37334SD62-373342026-10-28
B382SD62373360Surgical DirectSD62-37336SD62-373362026-10-28
B382SD67371410Surgical DirectSD67-37141SD67-371412026-10-28
B382SD6787200Surgical DirectSD67-8720SD67-87202026-10-28
B382SD77505940Surgical DirectSD77505-94SD77505-942026-10-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00190776435752MillenniumAvalign Technologies, Inc.GEI2026-10-21
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00841019124017KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
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00841019124048KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
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