SHEFA Block

Primary DI
00860008457417
Brand
SHEFA Block
Company
Shefa Solutions Inc.
Model
1
Published
2022-04-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860008457414PackageGS150Not in Commercial Distribution
20860008457411PackageGS15Not in Commercial Distribution
00860008457417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000845741410860008457414
2086000845741120860008457411
00860008457417008600084574178600084574170860008457417

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic bite block, basic, single-useA 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.

Regulatory Flags#

DUNS number
118646521
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008457400SHEFA Forcep12022-04-29
00860008457431SHEFA Forcep12022-04-29
10860008457414SHEFA Block12022-04-29