FDA.reportPublic FDA data

EasyPoint®

Primary DI
00613703853400
Brand
EasyPoint®
Company
RETRACTABLE TECHNOLOGIES, INC.
Model
85341
Catalog number
85341
Device description
21G 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
00613703853417PackageGS150In Commercial Distribution
00613703853424PackageGS18In Commercial Distribution
00613703853400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613703853417006137038534176137038534170613703853417
00613703853424006137038534246137038534240613703853424
00613703853400006137038534006137038534000613703853400

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
00613703853202EasyPoint®85321853212026-11-02
00613703853301EasyPoint®85331853312026-11-02
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
00613703853202EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853301EasyPoint®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
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00840216123847LiteTouchAsp Global, LLCFMI2026-10-30
00840216124288LiteTouchAsp Global, LLCFMI2026-10-30
05413206353712K-Pack IITerumo Europe NVFMI2026-10-28
20357515755043UltiCareULTIMED, INC.FMI2026-10-23
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00850002860733Comfort EZ Pro DuoS.D.I. USA, INC.FMI2026-09-28
10192253005059MonojectCardinal Health 200, LLCFMI2026-09-24
10809160538913HalyardMEDICAL ACTION INDUSTRIES INC.FMI2026-09-24