FDA.report

EXEL 1mL SYR W/ SAFETY NDL 23GX1" L-L

Primary DI
10020221270478
Brand
EXEL 1mL SYR W/ SAFETY NDL 23GX1" L-L
Company
Exel International
Model
27047
Catalog number
27047
Device description
EXEL 1mL SYR W/ SAFETY NDL 23GX1" L-L, 50/BX, 6BX/CS, 300/CS
Published
2023-03-17
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

Related Records

Product Codes

CodeName
MEGSyringe, Antistick

Product Code Classifications

CodeDeviceSpecialtyClass
MEGSyringe, AntistickGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10020221270478PackageGS150In Commercial Distribution
20020221270475PackageGS16In Commercial Distribution
00020221270471PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1002022127047810020221270478
2002022127047520020221270475
00020221270471000202212704710202212704710020221270471

GMDN Terms

TermDefinition
General-purpose syringe/needleA 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 non-retractable needle is included, either attached or detached (usually capped for user protection). It is intended for various medical applications and is not dedicated to medication administration. The syringe 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

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods

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

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