FDA.reportPublic FDA data

DANmed

Primary DI
04251351100031
Brand
DANmed
Company
DANNORITZER Medizintechnik GmbH & Co. KG
Model
LBA-000-000
Catalog number
LBA-000-000
Device description
Ring handle, bipolar Ø5mm
Published
2018-03-15
Public version status
Update
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251351100031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251351100031042513511000314251351100031

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
+497461962390udi@danrepair.de

Regulatory Flags#

DUNS number
314648911
Device count
1
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251351162701DANmedK5901A-THINK5901A-THIN2020-03-24
04251351162718DANmedK5901BK5901B2020-03-24
04251351162725DANmedK5901B-DK5901B-D2020-03-24
04251351162763DANmedK5901B-THINK5901B-THIN2020-03-24
04251351162770DANmedK5901CK5901C2020-03-24
04251351162787DANmedK5901C-DK5901C-D2020-03-24
04251351162831DANmedK5901C-THINK5901C-THIN2020-03-24
04251351162848DANmedK5901DK5901D2020-03-24
04251351162855DANmedK5901D-DK5901D-D2020-03-24
04251351162893DANmedK5901D-THINK5901D-THIN2020-03-24
04251351162909DANmedK5902AK5902A2020-03-24
04251351162916DANmedK5902A-DK5902A-D2020-03-24
04251351162954DANmedK5902A-THINK5902A-THIN2020-03-24
04251351162961DANmedK5902AEK5902AE2020-03-24
04251351162985DANmedK5902BK5902B2020-03-24
04251351162992DANmedK5902B-DK5902B-D2020-03-24
04251351163036DANmedK5902B-THINK5902B-THIN2020-03-24
04251351163043DANmedK5902BEK5902BE2020-03-24
04251351163067DANmedK5902CK5902C2020-03-24
04251351163128DANmedK5902CEK5902CE2020-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613327548129NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327548143NeptuneSTRYKER CORPORATIONGEI2024-12-10