Identity
- Trade Name
- SureGrip EUDAMEDMediflex FDA UDI
- Generic Name
- Wire/ligature passer, single-use FDA UDI
- Device Name
- Multipurpose Suture Grasper / Suture Grasper EUDAMEDSuture Grasper 1 per pack / Multipurpose Suture Passer / Grasper 1 per pack FDA UDI
- Model / Reference
- MSG-BT-A / D4001 EUDAMEDD4001 FDA UDI
- Description
- Suture Grasper 1 per pack / Multipurpose Suture Passer / Grasper 1 per pack FDA UDI
Identifiers
- Catalog Number
- D4001 FDA UDI
- Primary DI / UDI-DI
- 08904332600766 EUDAMEDFDA UDI
- Basic UDI-DI
- 089043326MSG00177 EUDAMED
- FDA Product Code
- HCF FDA UDIGCJ FDA UDI
- EMDN Code
- Z12029099 VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI–INVASIVE SURGERY – OTHER EUDAMED
- GMDN Term
- Wire/ligature passer, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI876.1500 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Wire/ligature passer, single-use
Mediflex by Endosys Healthcare India Private Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Wire/ligature passer, single-use.
- Arthrex® — Arthrex, Inc. · Class I
- Shuttle Pin — Trimed, INC. · Class I
- Shuttle Pin — Trimed, INC. · Class I
- LSSS — Lockdown Medical Ltd · Class I
- SuperCable® ISO-Elastic™ Cerclage System — Kinamed, Inc. · Class I
- Aesclepius Suture Cinch, Pack of 2 — AESCLEPIUS CORPORATION · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Shuttle Pin — Trimed, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Endosys Healthcare India Private Limited
Sources (2)
- FDA UDI 50718ee1-a514-45c9-a02b-831f4f98ac05 34 fields · synced Jul 25, 2026
- EUDAMED 85a4084a-6ed1-43e7-a73e-ee0602d5d665 61 fields · synced Jul 25, 2026