FDA.reportPublic FDA data

VanishPoint®

Primary DI
00613703901392
Brand
VanishPoint®
Company
RETRACTABLE TECHNOLOGIES, INC.
Model
90136
Catalog number
90136
Device description
"1mL 27G x 1/2"" Tuberculin VanishPoint Syringe Bulk Pack Non-Sterile "
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K980069000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980069000VANISHPOINT SYRINGERetractable Technologies, Inc.1998-02-12MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613703901392PrimaryGS10
00613703901354Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613703901392006137039013926137039013920613703901392
00613703901354006137039013546137039013540613703901354

GMDN Terms#

Term, Definition table
TermDefinition
Metered-delivery hypodermic syringe/needleA sterile device consisting of a graduated barrel (cylinder) with plunger and an attached retractable-needle, intended to be used to deliver an accurate metered dose of a substance (e.g., medicine or drug) during a patient injection. The syringe is typically made of plastic/silicone with an anti-sticking plunger allowing for smooth plunger movement; after use, the plunger is fully retracted into the barrel providing protection against needle sticks, and rendering the device unusable. It may be referred to as a safety syringe and can be used by healthcare personnel or patients. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
838024255
Device count
500
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
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

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Primary DI, Brand, Company table
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