FDA.reportPublic FDA data

Medline

Primary DI
10888277339484
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MDSE314MR
Catalog number
MDSE314MR
Device description
LAP,DISSECT,DUCKBILL,MONO HND,ROT,5MM
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HFICOAGULATOR, CULDOSCOPIC (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HFICoagulator, Culdoscopic (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K925114000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K925114000LAPAROSCOPIC INSTRUMENTSEndo Technic Corp.1994-02-28HFI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888277339484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088827733948410888277339484

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic grasping forceps, reusableA flexible, hand-held, manual device used in combination with a compatible endoscope to grasp tissue (typically atraumatically) or foreign bodies. It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a pair of scissors-like grasping tongs or claws which are operated by a control handle attached at the proximal end of the instrument; it is not an electrosurgical instrument. It is introduced into the body cavity through the working channel of the endoscope. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196320899MEDLINEMDS30310MDS303102026-09-25
10080196321407MEDLINEMDS30605MDS306052026-09-25
10080196321414MEDLINEMDS30607MDS306072026-09-25
10080196321438MEDLINEMDS30803MDS308032026-09-25
10080196321452MEDLINEMDS30805MDS308052026-09-25
10080196321469MEDLINEMDS30806MDS308062026-09-25
10080196321476MEDLINEMDS30807MDS308072026-09-25
10080196321483MEDLINEMDS30808MDS308082026-09-25
10080196321490MEDLINEMDS30809MDS308092026-09-25
10198459754210MEDLINEVASC1970VASC19702026-09-25
10198459754524MEDLINEVASC1971VASC19712026-09-25
10198459755699MEDLINEVASC1959VASC19592026-09-25
10198459755705MEDLINEVASC1962VASC19622026-09-25
10198459758287MEDLINEVASC1974VASC19742026-09-25
10198459758294MEDLINEVASC1975VASC19752026-09-25
10198459759291MEDLINEVASC1976VASC19762026-09-25
10198459760846MEDLINEVASC1977VASC19772026-09-25
10198459761850MEDLINEVASC1978VASC19782026-09-25
10198459766336MEDLINEVASC1979VASC19792026-09-25
10198459771224MEDLINEVASC1980VASC19802026-09-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00817401028423EndoplusEndoplusHFI2022-07-08
00817401028393EndoplusEndoplusHFI2022-03-10
00817401028140EndoplusEndoplusHFI2021-07-23
00817401027969EndoplusEndoplusHFI2021-05-26
00817401027976EndoplusEndoplusHFI2021-05-26
14042761086254OlympusOLYMPUS Winter & Ibe GmbHHFI2020-07-31
14042761086278OlympusOLYMPUS Winter & Ibe GmbHHFI2020-07-31
00817401027754EndoplusEndoplusHFI2020-06-26
00817401027495EndoplusEndoplusHFI2019-06-26
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