FDA.reportPublic FDA data

VanishPoint®

Primary DI
00613703130501
Brand
VanishPoint®
Company
RETRACTABLE TECHNOLOGIES, INC.
Model
13051
Catalog number
13051
Device description
3mL 21G x 5/8" VanishPoint® 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
MEGSyringe, Antistick

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEGSyringe, AntistickGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K946219000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K946219000POP-N-LOK SYRINGERetractable Technologies, Inc.1995-12-28MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613703130518PackageGS1100In Commercial Distribution
00613703130525PackageGS16In Commercial Distribution
00613703130501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613703130518006137031305186137031305180613703130518
00613703130525006137031305256137031305250613703130525
00613703130501006137031305016137031305010613703130501

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
00613703823106EasyPoint®82311823112026-11-02
00613703823304EasyPoint®82331823312026-11-02
00613703823908EasyPoint®82391823912026-11-02
00613703853103EasyPoint®85311853112026-11-02
00613703853202EasyPoint®85321853212026-11-02
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
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00840216124004LiteTouchAsp Global, LLCMEG2026-10-30
00840216124028LiteTouchAsp Global, LLCMEG2026-10-30
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20612479288557McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2026-10-08
20612479288588McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2026-10-08
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08056999020248SurTract™RONCADELLE OPERATIONS SRLMEG2026-05-31
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