FDA.reportPublic FDA data

Save-A-Tooth

Primary DI
00854498007986
Brand
Save-A-Tooth
Company
Smarthealth, Inc.
Model
SAT2411
Catalog number
SAT2411
Device description
Cell culture to sustain viability of knocked out tooth for implantation.
Published
2023-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KJFSystem, Suspension, Cell Culture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KJFSystem, Suspension, Cell CultureHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10854498007983PackageGS127In Commercial Distribution
00854498007986PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085449800798310854498007983
00854498007986008544980079868544980079860854498007986

GMDN Terms#

Term, Definition table
TermDefinition
Blood/tissue storage/culture containerA receptacle intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. It has a variety of shapes and sizes, may reduce the risk of contamination, may be used during freezing, and may be gas permeable. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
061081477
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D766406011SmartPractice40601406012016-09-08
D766SP6200181SmartPracticeSP620018SP6200182016-09-08
D766SP6200191SmartPracticeSP620019SP6200192016-09-08
00854498007108SmartPracticeAL71200AL712002020-12-02
00854498007115SmartPracticeAL71300AL713002020-12-02
00854498007146SmartPracticeAL7005AL70052020-12-02
00854498007153SmartPracticeAL7001AL70012020-12-02
00854498007160SmartPracticeAL7001PPAL7001PP2020-12-02
00854498007177SmartPracticeAL7002AL70022020-12-02
00854498007191SmartPracticeAL7000AL70002020-12-02
00854498007221SmartPracticeAL7003PPAL7003PP2020-12-02
00854498007245SmartPracticeAL7110AL71102020-12-15
00854498007269SmartPracticeAL7120PPAL7120PP2020-12-15
00854498007337SmartPracticeAL7004PPAL7004PP2020-12-02
00854498007344SmartPracticeAL7014AL70142020-12-02
00854498007351SmartPracticeAL7014PPAL7014PP2020-12-02
00854498007368SmartPracticeAL7100AL71002020-12-15
00854498007375SmartPracticeAL7210AL72102020-12-15
00854498007382SmartPracticeAL7220AL72202020-12-15
00854498007405SmartPracticeAL7201AL72012020-12-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850019717471G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2026-03-19
00850019717518G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2026-03-19
00850019717648G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2026-03-19
00850019717488G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2026-03-19
00850019717525G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2026-03-19
00850019717655G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2026-03-19
00850019717624G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2025-06-09
00850019717631G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2025-06-09
00850019717563G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2024-03-08
00850019717570G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2024-03-08
00850019717600G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2024-02-14
00850019717617G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2024-02-14
00850019717587G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2024-02-13
00850019717495G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2023-06-22
00850019717532G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2023-06-22
00850019717501G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2023-06-22
00850019717549G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2023-06-22
00850019717457G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2023-02-20
00850019717464G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2023-02-20
00850019717556G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2023-02-09
00850019717419G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-11-16
00850019717426G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-11-16
00850019717174G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-11-14
00850019717181G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-11-14
00850019717280G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-11-03
00850019717297G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-11-03
00850019717150G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-10-12
00850019717396G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-10-12
00850019717167G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-10-12
00850019717402G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-10-12