Identity
- Trade Name
- Mendit Reload Set FDA UDI
- Generic Name
- Soft-tissue/mesh anchor, bioabsorbable FDA UDI
- Device Name
- The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the pelvic floor. The Mendit Reload Set comprises two Applicator Cartridges, each with an Anchor-Suture unit (pre-loaded in the Applicator Cartridge). The Mendit is a disposable device supplied sterile, pre-loaded with the anchor-suture unit, and ready for use. FDA UDI
- Model / Reference
- Mendit Reload Set – Permanent Suture (Prolene USP 2-0) FDA UDI
- Description
- The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the pelvic floor. The Mendit Reload Set comprises two Applicator Cartridges, each with an Anchor-Suture unit (pre-loaded in the Applicator Cartridge). The Mendit is a disposable device supplied sterile, pre-loaded with the anchor-suture unit, and ready for use. FDA UDI
Identifiers
- Catalog Number
- ES0322 FDA UDI
- Primary DI / UDI-DI
- 07290019174059 FDA UDI
- 510(k) Number
- K213783 FDA UDI
- FDA Product Code
- PBQ FDA UDI
- GMDN Term
- Soft-tissue/mesh anchor, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
MR Conditional FDA UDI
Category: Soft-tissue/mesh anchor, bioabsorbable
Mendit Reload Set by Escala Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Soft-tissue/mesh anchor, bioabsorbable.
- OPTIFIX — Davol Inc. · Class II
- Integrity Implant Fixation Kit — Anika Therapeutics, Inc. · Class II
- OPTIFIX — Davol Inc. · Class II
- OPTIFIX — Davol Inc. · Class II
- TissueTak™ — Via Surgical , Ltd. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- FasTouch™ Absorbable — Via Surgical , Ltd. · Class II
- SORBAFIX — Davol Inc. · Class II
Cleared under the same submission
K213783 also covers:
- APYX Applicator Set — Escala Medical
- APYX Retriever Set — Escala Medical
- Mendit Applicator Set — Escala Medical
- Mendit Applicator Set — Escala Medical
- Mendit Applicator Set — Escala Medical
- Mendit Applicator Set — Escala Medical
- Mendit Reload Set — Escala Medical
- Mendit Reload Set — Escala Medical
- Mendit Reload Set — Escala Medical
- Mendit Reload Set — Escala Medical
- Mendit Reload Set — Escala Medical
- Mendit Retriever Set — Escala Medical
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Escala Medical
Sources (1)
- FDA UDI 2ce4816c-7235-4814-850a-4a5f9dd15f42 36 fields · synced May 30, 2026