FDA.reportPublic FDA data

Mediflex

Primary DI
08904332600513
Brand
Mediflex
Company
ENDOSYS HEALTHCARE INDIA PRIVATE LIMITED
Model
TPL5A180
Catalog number
TPL5A180
Device description
Port Free Retractor T-PEA Lifter with Std. 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
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NWVLaparoscopic Accessories, Gynecologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWVLaparoscopic Accessories, GynecologicObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08904332600513PackageGS110In Commercial Distribution
08904332600483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08904332600513089043326005138904332600513
08904332600483089043326004838904332600483

GMDN Terms#

Term, Definition table
TermDefinition
Externally-anchored laparoscopic retraction threadA sterile surgical device intended to be used during a laparoscopic procedure to provide hands-free retraction (through suspension) of lower abdominal, urogenital and pelvic structures, and synthetic tissues. It is a length of thread (i.e., suture-like) with a needle attached at one end and toggle at the other, intended to be introduced into the surgical cavity and manipulated typically using laparoscopic grasping forceps. Typically it is intended to be threaded through obstructive tissues, held in place by the toggle, and exit the abdominal wall to be externally anchored, allowing for transabdominal suspension of structures. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
872346468
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
08904332600476MediflexVBN10X05VBN10X052025-03-10
08904332600483MediflexTPL5A180TPL5A1802025-03-10
08904332600490MediflexTPL5X180TPL5X1802025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776421601MillenniumAvalign Technologies, Inc.NWV2026-05-05
00190776421250MillenniumAvalign Technologies, Inc.NWV2026-05-04
00190776421076MillenniumAvalign Technologies, Inc.NWV2026-04-30
00848657078368AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-04-23
00190776420277MillenniumAvalign Technologies, Inc.NWV2026-04-16
00190776418991MillenniumAvalign Technologies, Inc.NWV2026-04-13
00190776418427MillenniumAvalign Technologies, Inc.NWV2026-03-25
00190776418434MillenniumAvalign Technologies, Inc.NWV2026-03-25
00190776418441MillenniumAvalign Technologies, Inc.NWV2026-03-25
00848657078269AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-03-02
00190776417390MillenniumAvalign Technologies, Inc.NWV2026-02-27
00190776417406MillenniumAvalign Technologies, Inc.NWV2026-02-27
00190776417451MillenniumAvalign Technologies, Inc.NWV2026-02-27
00198506088520ELMED INCORPORATEDELMED INCORPORATEDNWV2026-02-23
00190776416072MillenniumAvalign Technologies, Inc.NWV2026-02-06
00190776415631MillenniumAvalign Technologies, Inc.NWV2026-02-02
00190776415648MillenniumAvalign Technologies, Inc.NWV2026-02-02
00190776415655MillenniumAvalign Technologies, Inc.NWV2026-02-02
00190776415402MillenniumAvalign Technologies, Inc.NWV2026-01-27
00848657078108AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-15
00848657078115AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-15
00848657078122AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-15
00848657077958AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-13
00848657077965AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-13
00848657078009AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-13
00198506086489ELMED INCORPORATEDELMED INCORPORATEDNWV2025-11-05
00190776414344MillenniumAvalign Technologies, Inc.NWV2025-10-23
00190776413910MillenniumAvalign Technologies, Inc.NWV2025-10-21
00190776413958MillenniumAvalign Technologies, Inc.NWV2025-10-21
00848657077682AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2025-10-15