Avalon Biomed NeoSEALER Flo – 0.5g EU Mini Kit, 4 Flex Flo Tips

Primary DI
00810118101243
Brand
Avalon Biomed NeoSEALER Flo – 0.5g EU Mini Kit, 4 Flex Flo Tips
Company
NUSMILE, LTD.
Model
ANSEMK
Device description
A paste product designed for endodontic surgery or perforations, and vital pulp therapy.
Published
2022-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810118101243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810118101243008101181012438101181012430810118101243

GMDN Terms#

Term, Definition table
TermDefinition
Hygroscopic dental cementA substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material, root canal sealer) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction of a hygroscopic inorganic compound(s) [e.g., calcium silicates, calcium aluminates, zinc sulfate, calcium sulfate] with water (hydration). It is intended to be either mixed with water prior to application or react with dentinal fluid in situ. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight0.5Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature72 Degrees Fahrenheit0 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
832-540-5964plara@nusmile.com

Regulatory Flags#

DUNS number
185497372
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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