FDA.reportPublic FDA data

HemeRX

Primary DI
00819235020000
Brand
HemeRX
Company
Sprig Oral Health Technologies, Inc.
Model
R-HRX
Device description
Hemostatic Cotton Pellets with Epinephrine
Published
2022-10-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MVLCord, Retraction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVLCord, RetractionUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819235020000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819235020000008192350200008192350200000819235020000

GMDN Terms#

Term, Definition table
TermDefinition
Gingival retraction cord, medicatedA medicated, cotton string used to temporarily hold off the gingiva during abutment preparation. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
029458526
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
00819235022189SmartMTA Capsule R-MTA-C102023-05-18
00819235022196SmartMTA CapsuleR-MTA-C202023-05-18
00819235020093EZCrownR-EZC-A-PK2022-12-05
00819235020109EZCrownR-EZC-A-SK2022-12-05
00819235020116EZCrownR-EZC-MAN-MK2022-12-05
00819235020123EZCrownR-EZC-MAN-PK2022-12-05
00819235020130EZCrownR-EZC-MAN-SK2022-12-05
00819235020147EZCrownR-EZC-MAX-SK2022-12-05
00819235020154EZCrownR-EZC-MAX-MK2022-12-05
00819235020161EZCrown R-EZC-MAX-PK2022-12-05
00819235020086EZCrownR-EZC-A-MK2022-12-01
00819235020192EZCrownR-EZC-P-A22022-12-01
00819235020208EZCrownR-EZC-P-A2SL2022-12-01
00819235020215EZCrownR-EZC-P-A32022-12-01
00819235020222EZCrownR-EZC-P-A3SL2022-12-01
00819235020239EZCrownR-EZC-P-A42022-12-01
00819235020246EZCrownR-EZC-P-A4SL2022-12-01
00819235020253EZCrownR-EZC-P-A52022-12-01
00819235020260EZCrownR-EZC-P-A5SL2022-12-01
00819235020277EZCrownR-EZC-P-A62022-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
J014660872140Retraxil blueKulzer GmbHMVL2026-04-21
J014660872150Retraxil blueKulzer GmbHMVL2026-04-21
J014661012760Retraxil blueKulzer GmbHMVL2026-04-21
J014661012770Retraxil blueKulzer GmbHMVL2026-04-21
J014661012780Retraxil blueKulzer GmbHMVL2026-04-21
00850079280274Sure CordHexa DentalMVL2026-03-04
00008579280274sure EndoHexa DentalMVL2026-01-22
00850079280182Sure EndoHexa DentalMVL2026-01-22
00850079280199Sure EndoHexa DentalMVL2026-01-22
00850079280205Sure endoHexa DentalMVL2026-01-22
00850079280212Sure EndoHexa DentalMVL2026-01-22
00850079280229Sure endoHexa DentalMVL2026-01-22
00850079280236Sure EndoHexa DentalMVL2026-01-22
00850079280243Sure EndoHexa DentalMVL2026-01-22
00850079280250Sure EndoHexa DentalMVL2026-01-22
00850079280267Sure EndoHexa DentalMVL2026-01-22
00850079280281SDure endoHexa DentalMVL2026-01-22
00850079280175Sure EndoHexa DentalMVL2026-01-21
10818207024968Traxodent Gel AlCl - Bulk Syringe KitVista DentalMVL2025-06-30
10818207024975Traxodent Gel AlCl - Sample PackVista DentalMVL2025-06-30
10818207024982Traxodent Gel AlCl - Value PackVista DentalMVL2025-06-30
10818207024999Traxodent Gel AlCl - Refill KitVista DentalMVL2025-06-30
10818207025002Traxodent Gel FS - Bulk Syringe KitVista DentalMVL2025-06-30
10818207025019Traxodent Gel FS - Value PackVista DentalMVL2025-06-30
10818207025026Traxodent Gel FS - Refill KitVista DentalMVL2025-06-30
00359883005665Tissue Goo™ Hemostatic Gel 4-PackDEN-MAT HOLDINGS, LLCMVL2025-03-18
00359883005672Tissue Goo™ Hemostatic Gel Big Shot Syringe KitDEN-MAT HOLDINGS, LLCMVL2025-03-18
00359883005634First String Advanced Braided Retraction Cord Non-Impregnated - SmallDEN-MAT HOLDINGS, LLCMVL2025-03-12
00359883005641First String Advanced Braided Retraction Cord Non-Impregnated - MediumDEN-MAT HOLDINGS, LLCMVL2025-03-12
00359883005658First String Advanced Braided Retraction Cord Non-Impregnated - LargeDEN-MAT HOLDINGS, LLCMVL2025-03-12