FDA.reportPublic FDA data

1 mL sterile syringe SNAP

Primary DI
10020221060505
Brand
1 mL sterile syringe SNAP
Company
Exel International
Model
26050SNAP
Catalog number
26050SNAP
Device description
SNAP 1ML LUER LOCK SYRINGE, 100/BX, 1000/CS WITH CUSTOM BARREL PRINT 1 mL sterile syringe, EXEL #26050, with luer lock tip and Pantone 7481 C green plunger with
Published
2023-04-04
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

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
K861153000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K861153000DISPOSABLE SYRINGES AND HYPODERMIC NEEDLESExel Intl.1986-04-23FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10020221060505PackageGS1100In Commercial Distribution
20020221060502PackageGS110In Commercial Distribution
00020221060508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1002022106050510020221060505
2002022106050220020221060502
00020221060508000202210605080202210605080020221060508

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
180572216
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
00020221012156Tandem Diabetes 3mL LL WITH CO-PACKED NEEDLE 26Gx3/8’’100121510012152023-04-17
00020221012163Tandem Diabetes 5mL LL WITH CO-PACKED NEEDLE 26Gx3/8’’100121610012162023-04-17
000202210605081 mL sterile syringe SNAP26050SNAP26050SNAP2023-04-04
00020221064483EXEL HYPO NDL 28GX3/4" T.W. 2,000/CS, 100PCS/BOX26448B26448B2023-04-06
00020221260175EXEL 0.3mL INS SYR 28GX1/2"26017260172023-03-20
00020221260199EXEL 0.3mL INS SYR 30GX1/2"26019260192023-03-14
00020221260236EXEL 1/2mL INS SYR 28GX1/2"26023260232024-11-25
00020221260243EXEL 1/2mL INS SYR 28GX1/2"26024260242023-03-15
00020221260328EXEL 1/2mL INS 28GX1/2"26032260322023-03-15
00020221260342EXEL 1mL INS 28GX1/2"26034260342023-03-15
00020221260366EXEL U-40 1/2mL INS SYR 29GX1/2"26036260362023-03-15
00020221260373EXEL U-40 1mL INS SYR 29GX1/2"26037260372023-03-15
00020221260380EXEL 1mL AMBER SYR ONLY LUER SLIP W/ TIP CAP26038260382023-03-15
00020221260458EXEL 1ml SYRINGE 26Gx3/8" L-S26045260452023-03-15
00020221260489EXEL Syringes26048260482016-09-20
00020221260519EXEL 1mL TB 21Gx1"-0-DEAD-SPACE26051260512023-03-15
00020221260564EXEL 1ml Syringe 25Gx1" LDS26056260562023-03-15
00020221260571EXEL 1ml Syringe 23Gx1"26057260572023-03-15
00020221260595EXEL 1mL LDS SYR 20G x 1" LUER LOCK26059260592023-03-15
00020221260601EXEL 1mL ALLERGY SYR 27GX1/2", REGULAR BEVEL26060260602023-03-15

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