FDA.reportPublic FDA data

Bipolar Forceps

Primary DI
00817984010907
Brand
Bipolar Forceps
Company
MECTRA LABS, INC.
Model
0600-BC3310-000
Catalog number
0600-BC3310-000
Device description
Bipolar Forceps Kleppinger-Style BC 34CM
Published
2019-01-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
10817984010904PackageGS15Not in Commercial Distribution
00817984010907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081798401090410817984010904
00817984010907008179840109078179840109070817984010907

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, bipolar, single-useA sterile 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, and may in addition be intended for open surgery; it is not intended for focal percutaneous ablation. 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 single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature20 Degrees Fahrenheit115 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-3968mectrasales@mectralabs.com

Regulatory Flags#

DUNS number
606939072
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817984011195Richard Wolf0600-2160-0000600-2160-0002019-01-29
00817984010211Electro Lube0600-EL101-0000600-EL101-0002019-01-24
00817984010228Electro Lube0600-EL102-0000600-EL102-0002019-01-28
00817984010402Electro Lavage0600-3100-0000600-3100-0002019-01-25
00817984010419Electro Lavage0600-3101-0000600-3101-0002019-01-25
00817984010426Electro Lavage0600-3102-0000600-3102-0002019-01-25
00817984010433Electro Lavage0600-3103-0000600-3103-0002019-01-25
00817984010440Electro Lavage0600-3110-0000600-3110-0002019-01-25
00817984010457Electro Lavage0600-3111-0000600-3111-0002019-01-25
00817984010464Electro Lavage0600-3112-0000600-3112-0002019-01-24
00817984010471Electro Lavage0600-3113-0000600-3113-0002019-01-25
00817984010488Electro Lavage0600-3120-0000600-3120-0002019-01-25
00817984010495Electro Lavage0600-3121-0000600-3121-0002019-01-25
00817984010501Electro Lavage0600-3122-0000600-3122-0002019-01-29
00817984010518Electro Lavage0600-3123-0000600-3123-0002019-01-25
00817984010525Electro Lavage0600-3130-0000600-3130-0002019-01-25
00817984010532Electro Lavage0600-3131-0000600-3131-0002019-01-29
00817984010549Electro Lavage0600-3132-0000600-3132-0002019-01-25
00817984010556Electro Lavage0600-3133-0000600-3133-0002019-01-25
00817984010563Electro Lavage0600-3140-0000600-3140-0002019-01-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506089381ELMED INCORPORATEDELMED INCORPORATEDHIN2026-04-02
05708265016389LiNA Bipolar Loop™LiNA Medical AGHIN2026-04-02
05708265016402LiNA Bipolar Loop™LiNA Medical AGHIN2026-04-02
05708265016426LiNA Bipolar Loop™LiNA Medical AGHIN2026-04-02
B382SD80055210Surgical DirectSurgical Direct, Inc.HIN2026-02-12
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
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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