AccessGUDID - DEVICE: Mendit Bi-Lateral Applicator Set (07290019174059)

GUDID

Device Identifier (DI) Information

Brand Name: Mendit Bi-Lateral Applicator Set
Version or Model: Mendit Bi-Lateral Applicator Set– Non Resorbable suture
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ES0322
Company Name: ESCALA MEDICAL LTD

Primary DI Number: 07290019174059
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600469711 *Terms of Use

Device Description: The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the pelvic floor. The Mendit device Bi-Lateral Set comprises the following elements: Applicator – a delivery system comprising two Applicator Cartridge, each with an Anchor-Suture unit (pre-loaded in the Applicator Cartridge). The Apyx is a disposable device supplied sterile, pre-loaded with the anchor-suture unit, and ready for use.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PBQ	Fixation, Non-Absorbable Or Absorbable, For Pelvic Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K213783	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -10 and 40 Degrees Celsius
Special Storage Condition, Specify: Keep Dry
Special Storage Condition, Specify: Keep Away from Sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2ce4816c-7235-4814-850a-4a5f9dd15f42
Public Version Date: October 31, 2023
Public Version Number: 1
DI Record Publish Date: October 23, 2023