FDA UDI
In Commercial Distribution
🇺🇸 United States
Mendit applicator set
DI: 07290019174097
·
Model: Mendit applicator set - permanent suture (ePTFE 2-0)
·
ESCALA MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Mendit applicator set
- Primary DI
- 07290019174097
- Version / Model
- Mendit applicator set - permanent suture (ePTFE 2-0)
- Catalog Number
- ES0510
- Company Name
- ESCALA MEDICAL LTD
- Labeler DUNS
- 600469711
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-05
- Public Version
- 1
- Public Version Date
- 2024-06-13
- Public Version Status
- New
- Public Device Record Key
- 0bcb98ee-786c-433a-b5a0-67dbf83c1a3b
Device Description
The Applicator comprises of the Applicator Cartridge and Handle. Upon insertion and guidance to the ligament it enables the deployment and attachment of the pre-loaded anchor- suture unit at the designated position 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 | 07290019174097 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213783 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -10 – 40 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep away from sunlight