FDA.reportPublic FDA data

Retrax Gel FS ProPack SAMPLE

Primary DI
00310866001692
Brand
Retrax Gel FS ProPack SAMPLE
Company
PASCAL COMPANY, INC.
Model
88103
Catalog number
88103
Device description
Topical hemostatic gel with 15.5% ferric sulfate, 12 - 0.75g syringes
Published
2022-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
00310866002347PrimaryGS10
00310866002385PrimaryGS10
00310866001692Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00310866002347003108660023473108660023470310866002347
00310866002385003108660023853108660023850310866002385
00310866001692003108660016923108660016920310866001692

GMDN Terms#

Term, Definition table
TermDefinition
Gingival retraction solutionA liquid substance used in dentistry to induce gingival retraction by in situ impregnation of a non-medicated gingival retraction cord. It induces contraction of the upper strata of the free gingiva typically through the action of an astringent agent (e.g., aluminium chloride). This device may also induce a local stasis of gingival exudates and gingival haemorrhages. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight0.75Gram

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8004268051pascal@pascaldental.com

Regulatory Flags#

DUNS number
009260217
Device count
2
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00310866000732Retrax Cord Cutter26440264402019-01-24
00310866002552KOIS KR-1 PACKER262252024-06-04
00310866002606KOIS KR-2 PACKER262262024-06-04
00310866002613KOIS KR-3 PACKER262272024-06-04
00310866002620KOIS KR-4 PACKER262282024-06-04
00310866002637KOIS KR-5 PACKER262292024-06-04
00310866002644GET SCULPTED26-31026-3102024-05-16
00310866002651Fluorilaq Salted Caramel (10mL) Tube104022024-03-28
00310866002668Fluorilaq Mint (10mL) Tube104062024-03-28
00310866002408Racord Plus Retraction Cord 7/0007797077972021-11-22
00310866002415Racord Plus Retraction Cord 8/007800078002021-11-22
00310866002422Racord Plus Retraction Cord 9/107810078102021-11-22
00310866002439Racord Plus Retraction Cord 10/207820078202021-11-22
00310866000800Retrax Pellets12400124002019-01-31
00310866000275KnitTrax Plain Retraction Cord 00007569075692019-01-29
00310866000282KnitTrax Plain Retraction Cord 0007570075702019-01-29
00310866000299KnitTrax Plain Retraction Cord 007575075752019-01-29
00310866000305KnitTrax Plain Retraction Cord 107580075802019-01-29
00310866000312KnitTrax Plain Retraction Cord 207585075852019-01-29
00310866000329SilTrax AS Retraction Cord 7/0007097070972019-01-24

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
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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