FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD80055210
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD8005-521
Catalog number
SD8005-521
Device description
5mm, 34cm Bipolar Grasping Forceps, Modular; Three-Piece, Power-Grip Handle
Published
2026-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HINCOAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HINCoagulator-Cutter, Endoscopic, Bipolar (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD80055210PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, bipolar, reusableAn electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery; it may in addition be intended for open surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). 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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382SD484610Surgical DirectSD48461SD484612026-07-09
B382SD484630Surgical DirectSD48463SD484632026-07-09
B382SD484640Surgical DirectSD48464SD484642026-07-09
B382SD484650Surgical DirectSD48465SD484652026-07-09
B382SD484660Surgical DirectSD48466SD484662026-07-09
B382SD484670Surgical DirectSD48467SD484672026-07-09
B382SD484680Surgical DirectSD48468SD484682026-07-09
B382SD484690Surgical DirectSD48469SD484692026-07-09
B382SD484700Surgical DirectSD48470SD484702026-07-09
B382SD484710Surgical DirectSD48471SD484712026-07-09
B382SD484720Surgical DirectSD48472SD484722026-07-09
B382SD49400B0Surgical DirectSD49400BSD49400B2026-07-09
B382SD49401B0Surgical DirectSD49401BSD49401B2026-07-09
B382SD49402B0Surgical DirectSD49402BSD49402B2026-07-09
B382SD49403B0Surgical DirectSD49403BSD49403B2026-07-09
B382SD49404B0Surgical DirectSD49404BSD49404B2026-07-09
B382SD49405B0Surgical DirectSD49405BSD49405B2026-07-09
B382SD49406B0Surgical DirectSD49406BSD49406B2026-07-09
B382SD49407B0Surgical DirectSD49407BSD49407B2026-07-09
B382SD49408B0Surgical DirectSD49408BSD49408B2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506089381ELMED INCORPORATEDELMED INCORPORATEDHIN2026-04-02
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05708265016402LiNA Bipolar Loop™LiNA Medical AGHIN2026-04-02
05708265016426LiNA Bipolar Loop™LiNA Medical AGHIN2026-04-02
00842180135437ELMED INCORPORATEDELMED INCORPORATEDHIN2025-09-29
00842180135475ELMED INCORPORATEDELMED INCORPORATEDHIN2025-09-29
00198506026027ELMED INCORPORATEDELMED INCORPORATEDHIN2025-05-22
00198506026034ELMED INCORPORATEDELMED INCORPORATEDHIN2025-03-11
00198506020841ELMED INCORPORATEDELMED INCORPORATEDHIN2025-03-05
06976860690375ClearVisionOriGyn Medical Technology (Hangzhou) Co., Ltd.HIN2024-09-23
06976860690382ClearVisionOriGyn Medical Technology (Hangzhou) Co., Ltd.HIN2024-09-23
06976860690399ClearVisionOriGyn Medical Technology (Hangzhou) Co., Ltd.HIN2024-09-23
06976860690405ClearVisionOriGyn Medical Technology (Hangzhou) Co., Ltd.HIN2024-09-23
00887482128596Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.HIN2024-09-09
00887482128602Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.HIN2024-09-09
00198506060731ELMED INCORPORATEDELMED INCORPORATEDHIN2024-08-26
00190776126421MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776126438MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776127121MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776127152MillenniumAvalign Technologies, Inc.HIN2023-11-14
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00190776127626MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776127817MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776131661MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776142476MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776381851MillenniumAvalign Technologies, Inc.HIN2023-11-13
00190776376093MillenniumAvalign Technologies, Inc.HIN2023-09-08
00190776376109MillenniumAvalign Technologies, Inc.HIN2023-09-08
00190776377250MillenniumAvalign Technologies, Inc.HIN2023-09-08
00842180172012ELMEDELMED INCORPORATEDHIN2023-06-20