Ventral Wall Defect Silo Bag

Basic Information

• Brand Name: Ventral Wall Defect Silo Bag
• Primary DI: 00684995400054
• Version / Model: GR74089-06
• Company Name: BENTEC MEDICAL OPCO, LLC
• Labeler DUNS: 080524654
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-03
• Public Version: 4
• Public Version Date: 2019-05-10
• Public Version Status: Update
• Public Device Record Key: 415da056-1b3c-4c40-90c9-a09e1c037725

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	878.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62143	Gastroschisis silo bag	A sterile, synthetic polymer bag intended to contain and isolate the protruding intestine of a neonate with gastroschisis to minimize heat and exudate loss, stabilize the protruding gut, and assist retraction of the herniation. It is typically intended to completely cover the protruding gut down to the peritoneum, be adhered to the abdomen, and then suspended; supportive devices (i.e., adhesive dressings, suspension tubing) may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00684995400054	GS1

Premarket Submissions

Submission Number	Supplement Number
K840172	000