SHEFA Block

Basic Information

• Brand Name: SHEFA Block
• Primary DI: 00860008457417
• Version / Model: 1
• Company Name: Shefa Solutions Inc.
• Labeler DUNS: 118646521
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-29
• Public Version: 2
• Public Version Date: 2022-11-08
• Public Version Status: Update
• Public Device Record Key: 17251d69-1725-4684-9d71-20cd0bf1645a
• Distribution End Date: 2022-10-01

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Serial Number: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
34143	Endoscopic bite block, basic, single-use	A device intended to be inserted into a patient''s mouth to maintain oral patency during an endoscopic procedure primarily to protect the endoscope, introduced via the mouth, from the patient''s natural tendency to bite down on the instrument, thereby causing damage. The device is also intended to protect the tongue and teeth of the patient during endoscopy. It is a basic device and does not include additional functions/features such as lumen to support introduction of an oxygen (O2) line. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10860008457414	GS1	Inner Box	50	Not in Commercial Distribution	2022-10-01
Primary	00860008457417	GS1
Package	20860008457411	GS1	Outer Box	5	Not in Commercial Distribution	2022-10-01