FDA.reportPublic FDA data

EasyPoint®

Primary DI
00613703820303
Brand
EasyPoint®
Company
RETRACTABLE TECHNOLOGIES, INC.
Model
82031
Catalog number
82031
Device description
"23G x 1"" EasyPoint® Needle"
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133635000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133635000EASYPOINT NEEDLERetractable Technologies, Inc.2014-06-17FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613703820310PackageGS150In Commercial Distribution
00613703820327PackageGS18In Commercial Distribution
00613703820303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613703820310006137038203106137038203100613703820310
00613703820327006137038203276137038203270613703820327
00613703820303006137038203036137038203030613703820303

GMDN Terms#

Term, Definition table
TermDefinition
Needle guardA cap/cover intended to be extended over a used needle (attached to a syringe/autoinjector or not) to prevent accidental needle sticks, typically during removal of the needle. It is typically a plastic housing with appropriate shielding to prevent injury upon application, and is typically disposed of with the needle; it is not the needle cap provided with the needle. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
888-703-1010rtiservice@vanishpoint.com

Regulatory Flags#

DUNS number
838024255
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00613703101303VanishPoint®10131101312016-09-22
00613703101501VanishPoint®10151101512016-09-22
00613703102102VanishPoint®10211102112016-09-22
00613703102300VanishPoint®10231102312016-09-22
00613703102508VanishPoint®10251102512016-09-22
00613703102706VanishPoint®10271102712016-09-22
00613703102805VanishPoint®10281102812016-09-22
00613703102904VanishPoint®10291102912016-09-22
00613703152206VanishPoint®15221152212016-09-22
00613703152701VanishPoint®15271152712016-09-22
00613703152909VanishPoint®15291152912016-09-22
00613703153708VanishPoint®15371153712018-04-27
00613703153906VanishPoint®15391153912018-04-27
00613703312204VanishPoint®31221312212016-09-22
00613703313300VanishPoint®31331313312016-09-22
00613703314406VanishPoint®31441314412016-09-22
00613703315403VanishPoint®31541315412016-09-22
00613703316400VanishPoint®31641316412016-09-22
00613703317407VanishPoint®31741317412016-09-22
00613703352200VanishPoint®35221352212016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10809160538913HalyardMEDICAL ACTION INDUSTRIES INC.FMI2026-09-24
16972857299252REDOX SMART PAN Pen NeedleSandstone Medical (Suzhou) Inc.FMI2026-09-24
MHC18290272EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18310472EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18313672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18320872EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18323672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
00850091070013CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070235CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070242CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070259CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070266CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070273CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070280CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
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00850091070303CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070310CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070327CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070334CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070341CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070365CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070433CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850068519361SAM MedicalZien Medical Technologies, LLCFMI2026-09-03
00850068519378SAM MedicalZien Medical Technologies, LLCFMI2026-09-03
00850068519385SAM MedicalZien Medical Technologies, LLCFMI2026-09-03
00814965020481Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020504Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020528Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020542Precision PointGold Coast Medical Supply, LPFMI2026-08-26