FDA.reportPublic FDA data

EasyPoint®

Primary DI
00613703853202
Brand
EasyPoint®
Company
RETRACTABLE TECHNOLOGIES, INC.
Model
85321
Catalog number
85321
Device description
22G x 1" EasyPoint® Needle with 3mL syringe
Published
2026-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
00613703853219PackageGS150In Commercial Distribution
00613703853226PackageGS18In Commercial Distribution
00613703853202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613703853219006137038532196137038532190613703853219
00613703853226006137038532266137038532260613703853226
00613703853202006137038532026137038532020613703853202

Contacts#

Phone, Email table
PhoneEmail
8887031010rtiservice@retractable.com

Regulatory Flags#

DUNS number
838024255
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00613703130501VanishPoint®13051130512026-11-02
00613703823106EasyPoint®82311823112026-11-02
00613703823304EasyPoint®82331823312026-11-02
00613703823908EasyPoint®82391823912026-11-02
00613703853103EasyPoint®85311853112026-11-02
00613703853301EasyPoint®85331853312026-11-02
00613703853400EasyPoint®85341853412026-11-02
00613703853509EasyPoint®85351853512026-11-02
00613703853608EasyPoint®85361853612026-11-02
00613703853707EasyPoint®85371853712026-11-02
00613703853806EasyPoint®85381853812026-11-02
00613703853905EasyPoint®85391853912026-11-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00613703823106EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703823304EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703823908EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853103EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853301EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853400EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853509EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853608EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853707EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853806EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853905EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00840216124264LiteTouchAsp Global, LLCFMI2026-11-02
00840216123793LiteTouchAsp Global, LLCFMI2026-10-30
00840216123823LiteTouchAsp Global, LLCFMI2026-10-30
00840216123847LiteTouchAsp Global, LLCFMI2026-10-30
00840216124288LiteTouchAsp Global, LLCFMI2026-10-30
05413206353712K-Pack IITerumo Europe NVFMI2026-10-28
20357515755043UltiCareULTIMED, INC.FMI2026-10-23
16972857299337Pen Needles ClassicSandstone Medical (Suzhou) Inc.FMI2026-10-11
16972857299290Easydrip Readygard DuoSandstone Medical (Suzhou) Inc.FMI2026-10-09
16972857299306Easydrip ReadygardSandstone Medical (Suzhou) Inc.FMI2026-10-09
16972857299313Easydrip ReadygardSandstone Medical (Suzhou) Inc.FMI2026-10-09
00050428167243TRUEplusTRIVIDIA HEALTH, INC.FMI2026-10-07
00050428167267TRUEplusTRIVIDIA HEALTH, INC.FMI2026-10-07
06958697621821One+Step INSULIN PEN NEEDLEANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTDFMI2026-10-01
M99230402912120LCH3Livaclean HealthCarelife (usa) Inc.FMI2026-09-30
M99230403250120LCH3Livaclean HealthCarelife (usa) Inc.FMI2026-09-30
00850002860733Comfort EZ Pro DuoS.D.I. USA, INC.FMI2026-09-28
10192253005059MonojectCardinal Health 200, LLCFMI2026-09-24
10809160538913HalyardMEDICAL ACTION INDUSTRIES INC.FMI2026-09-24