FDA.reportPublic FDA data

Mediflex

Primary DI
08904332600476
Brand
Mediflex
Company
ENDOSYS HEALTHCARE INDIA PRIVATE LIMITED
Model
VBN10X05
Catalog number
VBN10X05
Device description
Port Free Retractor Versa Lifter Band with Long Needle
Published
2025-03-10
Public version status
New
Distribution status
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
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08904332600506PackageGS15In Commercial Distribution
08904332600476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08904332600506089043326005068904332600506
08904332600476089043326004768904332600476

GMDN Terms#

Term, Definition table
TermDefinition
Internally-anchored endoscopic retractorA sterile, nonimplantable, intraoperative surgical instrument designed to be inserted into the abdominal or thoracic cavity through a compatible endoscopic instrument (e.g., an access port) to provide hands-free retraction of a selected organ by anchoring it to the cavity wall during a surgical intervention (e.g., gastroenterological, gynaecological and urological laparoscopic or thoracoscopic procedures). It is inserted using a dedicated applier and typically consists of two interconnected clips that clutch the tissue for anchoring to the cavity wall and grasping the organ. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+91 9820422965info@endosyshealthcare.com

Regulatory Flags#

DUNS number
872346468
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08904332600216Mediflex4005B4005B2020-12-18
08904332600681Mediflex4105S-504105S-502025-11-04
08904332600698Mediflex4105B-504105B-502025-11-04
08904332600704Mediflex4112B-504112B-502025-11-04
08904332600711Mediflex412FB-50412FB-502025-11-04
08904332600766MediflexD4001D40012025-05-19
08904332600773MediflexD4001D40012025-05-19
08904332600582Mediflex4105S-22025-05-13
08904332600599Mediflex4105B-22025-05-13
08904332600605Mediflex4112B-22025-05-13
08904332600612Mediflex4107F-22025-05-13
08904332600629Mediflex412FB-22025-05-13
08904332600636Mediflex4105S-22025-05-13
08904332600643Mediflex4105B-22025-05-13
08904332600650Mediflex4112B-22025-05-13
08904332600667Mediflex4107F-22025-05-13
08904332600674Mediflex412FB-22025-05-13
08904332600483MediflexTPL5A180TPL5A1802025-03-10
08904332600490MediflexTPL5X180TPL5X1802025-03-10
08904332600506MediflexVBN10X05VBN10X052025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810143909609SURGIPROSSurgipros, LLCGAD2026-07-30
00810212930343SURGIPROSSurgipros, LLCGAD2026-07-30