FDA.reportPublic FDA data

Mediflex

Primary DI
08904332600766
Brand
Mediflex
Company
ENDOSYS HEALTHCARE INDIA PRIVATE LIMITED
Model
D4001
Catalog number
D4001
Device description
Suture Grasper 1 per pack / Multipurpose Suture Passer / Grasper 1 per pack
Published
2025-05-19
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

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery
HCFInstrument, Ligature Passing And Knot Tying

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
HCFInstrument, Ligature Passing And Knot TyingGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08904332600773PackageGS15In Commercial Distribution
08904332600766PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08904332600773089043326007738904332600773
08904332600766089043326007668904332600766

GMDN Terms#

Term, Definition table
TermDefinition
Wire/ligature passer, single-useA sterile, hand-held, manual surgical instrument designed for passing a length of a flexible material/device, typically a wire, ligature, or orthopaedic graft gauge, through a surgical site by creating a pathway through tissue and facilitating the introduction and handling of the material/device. It may also be referred to as a carrier and is typically in the form of a shaft with a distal clasp, grasping arm, or cannulated hook to hold the material being passed through the tissue. This is a single-use device.

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
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
08904332600506MediflexVBN10X05VBN10X052025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506092183ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506092640ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506093562ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506093838ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
B354OSRP80Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-07-29
00198506092435ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-28
00198506092855ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-28
00198506093289ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-28
00198506093388ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-28
00842102116452Deluxe Laparoscopic InstrumentsFLEXBAR MACHINE CORPORATIONGCJ2026-07-28
14026704645340WECKTELEFLEX INCORPORATEDGCJ2026-07-28
B382SD901365500Surgical DirectSurgical Direct, Inc.GCJ2026-07-28
00190776422110MillenniumAvalign Technologies, Inc.GCJ2026-07-24
00198506091957ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-22
00198506092848ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-22
00198506092862ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-22
14026704645333WECKTELEFLEX INCORPORATEDGCJ2026-07-21
00198506092176ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-17
00888867561793Arthrex®ARTHREX, INC.GCJ2026-07-17
B382SD90781001000Surgical DirectSurgical Direct, Inc.GCJ2026-07-17
B382SD9918100Surgical DirectSurgical Direct, Inc.GCJ2026-07-17
B382SD1184590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD12711090Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD1271390Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD1271590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13018770Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13168350Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD23373490Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD770561050Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD775011530Surgical DirectSurgical Direct, Inc.GCJ2026-07-14