FDA.reportPublic FDA data

Medline

Primary DI
10884389936184
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MDS523369TA
Catalog number
MDS523369TA
Device description
LAP,GRASPER,BOWEL,FENESTRATED,5MM,45MM
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
K151567000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151567000ENDOPLUS hand-held laparoscopic instrumentsEndoplus2015-12-23HFI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884389936184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088438993618410884389936184

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery dissectorA hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, comes in various shapes and sizes. This is a reusable device.

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
10080196320417MEDLINEMDS30102MDS301022026-09-09
10080196320424MEDLINEMDS30103MDS301032026-09-09
10080196320431MEDLINEMDS30104MDS301042026-09-09
10080196320509MEDLINEMDS30202MDS302022026-09-09
10080196320523MEDLINEMDS30204MDS302042026-09-09
10080196320530MEDLINEMDS30205MDS302052026-09-09
10080196320660MEDLINEMDS30301MDS303012026-09-09
10080196320721MEDLINEMDS30302MDS303022026-09-09
10080196320752MEDLINEMDS30303MDS303032026-09-09
10080196320790MEDLINEMDS30304MDS303042026-09-09
10080196320806MEDLINEMDS30305MDS303052026-09-09
10080196321179MEDLINEMDS30405MDS304052026-09-09
10080196321384MEDLINEMDS30603MDS306032026-09-14
10197344220083MEDLINEDYNJP2530TWLDYNJP2530TWL2026-09-18
10197344220090MEDLINEDYNJP2540TWLDYNJP2540TWL2026-09-18
10888277198739MEDLINEMDT821231QMDT821231Q2026-09-18
10888277688896MEDLINEMDS30106BMDS30106B2026-09-18
10888277688902MEDLINEMDS30107BMDS30107B2026-09-18
10888277688919MEDLINEMDS30108BMDS30108B2026-09-18
10888277688926MEDLINEMDS30109BMDS30109B2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817401029048EndoplusEndoplusHFI2024-08-30
00817401028416EndoplusEndoplusHFI2022-07-08
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
00887482032961Symmetry AllisASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482032978Symmetry AllisASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482033036Symmetry Surgical®ASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482033135Symmetry Surgical®ASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482033289SymmetryASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482033302Symmetry ASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482033326SymmetryASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482033333Symmetry ASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482033371Symmetry Surgical®ASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482033388Symmetry ASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482033395Symmetry MixterASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482033487SymmetryASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482033531Symmetry Surgical®ASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482033609Symmetry Surgical®ASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482033623Symmetry ASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482062128Symmetry BabcockASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482074343Symmetry Surgical®ASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482086193Symmetry Surgical®ASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482086209Symmetry ASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25