FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040025960
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5700348
Catalog number
5700348
Device description
Retreat GRP Capsule
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MVLCORD, RETRACTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVLCord, RetractionUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050180000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050180000EXPA-SYLProduits Dentaires Pierre Rolland2005-02-11MVL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040025960PrimaryGS10
00304040025963Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404002596010304040025960
00304040025963003040400259633040400259630304040025963

GMDN Terms#

Term, Definition table
TermDefinition
Gingival retraction kitA collection of sterile dental instruments and other items used to hold off the gingiva during abutment preparation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Weight1Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
012430880
Device count
20
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14
10304040197018Henry Schein570586857058682026-05-14
10304040059446Henry Schein900445490044542019-02-13
10304040196790Henry Schein570584657058462026-04-21
10304040196806Henry Schein570584957058492026-04-21
10304040196660Henry Schein570583757058372026-04-17
10304040196677Henry Schein570583857058382026-04-17
10304040196684Henry Schein570583957058392026-04-17
10304040196691Henry Schein570584057058402026-04-17
10304040196707Henry Schein570584157058412026-04-17
10304040196714Henry Schein570584257058422026-04-17
10304040196653Henry Schein570583157058312026-04-10
00304040000236Henry Schein100-7773100-77732015-09-25
10304040119034Henry Schein570163357016332020-02-05
10304040119058Henry Schein570163457016342020-02-05
10304040119065Henry Schein570163657016362020-02-05
10304040119089Henry Schein570163857016382020-02-05

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