Procedure Products Syringe

Primary DI
B1604410W2
Brand
Procedure Products Syringe
Company
PROCEDURE PRODUCTS, INC.
Model
4410-W
Device description
5CC LOCK STANDARD SYRINGE, WHITE
Published
2017-02-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K874747000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K87474700010CC SYRINGE CONTROL RING SETProcedure Products, Inc.1988-02-04FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B1604410W2PackageHIBCC25In Commercial Distribution
B1604410W1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
151507563
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B1602118351Procedure Products Needles21-18352017-02-07
B1602293571Procedure Products needles229-3572017-04-03
B1603118221Procedure Products Needle31-18222017-02-07
B1603293551Procedure Products needles329-3552017-04-03
B1603293571Procedure Products Needle329-3572016-12-01
B1603118451Procedure Products Needle31-18452020-03-10
B1602018221Procedure Products needles20-18222017-04-03
B1602018271Procedure Products Needle20-18272016-12-01
B1602018401Procedure Products Needles20-184020-18402018-01-02
B1602118271Procedure Products Needle21-18272016-12-01
B160211827P1Procedure Products Needles21-1827-P2017-09-27
B1603118151Procedure Products Needles31-18152017-02-07
B1603118271Procedure Products Needle31-18272016-12-01
B160311827P1Procedure Products Needles31-1827-P2017-09-27
B1603118351Procedure Products Syringes31-18352017-02-07
B1603118601Procedure Products Needle31-186031-18602018-01-02
B1603121151Procedure Products Needle31-21152017-09-12
B16032M18601Procedure Products Needle32M-18602017-02-07
B1605118271Procedure Products Needle51-18272016-12-01
B1605518291Procedure Products Needles55-182955-18292018-01-02

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