FDA UDI
In Commercial Distribution
🇺🇸 United States
Mendit Retriver Universal Set
DI: 07290019174257
·
Model: Mendit Retriver Universal Set
·
ESCALA MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Mendit Retriver Universal Set
- Primary DI
- 07290019174257
- Version / Model
- Mendit Retriver Universal Set
- Catalog Number
- ES0648
- Company Name
- ESCALA MEDICAL LTD
- Labeler DUNS
- 600469711
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-10
- Public Version
- 1
- Public Version Date
- 2026-03-18
- Public Version Status
- New
- Public Device Record Key
- 069ab9cc-b12d-4c5f-b05d-0c5b2cf051de
Device Description
The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the pelvic floor. The Mendit Retriver Universal Set comprises one Retriever Cartridge, and suture passer accessory. The Retriever Cartridge operated by the Handle is used to retrieve the anchor-suture assembly after it has been placed on ligament.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PBQ | Fixation, Non-Absorbable Or Absorbable, For Pelvic Use | Obstetrics/Gynecology | 884.4530 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45027 | Soft-tissue/mesh anchor, bioabsorbable | A bioabsorbable device designed to be implanted into ligaments or other soft tissues for soft-tissue approximation and/or to serve as a site of attachment for surgical mesh or sutures; it is not intended to anchor soft tissues to bone, nor repair cartilage, and is not intended for ophthalmic use. It is available in a variety of designs (e.g., screw-, punch-, staple-like) and is made of a polymer that can be chemically degraded via natural body processes. It is intended to create a fixed anchor point and is not a suture-based fastening device such as a T-fastener. It is typically implanted with the use of a specialized applicator which may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290019174257 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep away from sunlight
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 25 Degrees Celsius