FDA.reportPublic FDA data

DANmed

Primary DI
04251351109218
Brand
DANmed
Company
DANNORITZER Medizintechnik GmbH & Co. KG
Model
LME-144-025
Catalog number
LME-144-025
Device description
LAP-Instrument, Ø5mm, l=250mm, flushp. Grasping forceps DUVAL, d/a Stainl.steel handle, insul., w. ratchet
Published
2018-03-13
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052759000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052759000DAN MONOPOLAR LAP ACCESSORIESDannoritzer Medizintechnik GmbH & Co. KG2006-06-14GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251351109218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251351109218042513511092184251351109218

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic grasping forceps, reusableA rigid surgical instrument designed to be introduced through a laparoscope primarily for grasping and manipulating tissues during a laparoscopic surgical procedure. It is a hand-held device typically with scissors-like handles that may include a ratchet mechanism; a long slender shaft; and one of a variety of distal tips with single or double action and frequently rotating jaws (e.g., duckbill, alligator) controlled by a knob at the handle. 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
00190776402143MillenniumAvalign Technologies, Inc.GEI2026-07-19
00198506092756ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
00198506092923ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
B382SD89239290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89509290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89529290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89759150Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89819320Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839280Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89914450Surgical DirectSurgical Direct, Inc.GEI2026-07-17
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
08800020100276INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100283INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100306INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100313INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100320INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100337INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020104984DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020104991DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105004DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105059DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105066DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105073DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020106827DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020107626DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020107633DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110565INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110572INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110640FootswitchJeisys Medical Inc.GEI2026-07-16