FDA.report

SyringePro

Primary DI
00860003864708
Brand
SyringePro
Company
SLANTED ADAPTOR LLC
Model
10mLNSSU
Catalog number
10mLNSSU
Device description
10-12 mL Standard Syringe Size, Non-sterile, Single-Use, syringe adaptor. Single patient visit use. Count 20. Syringe accessory for comfort and ergonomic support
Published
2020-11-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
IQGAdaptor, Holder, Syringe

Product Code Classifications

CodeDeviceSpecialtyClass
IQGAdaptor, Holder, SyringePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00860003864708PrimaryGS10
00860003864715Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003864708008600038647088600038647080860003864708
00860003864715008600038647158600038647150860003864715

GMDN Terms

TermDefinition
Syringe-loaded medication/vaccine injector, manual, professionalA hand-held, manually-powered mechanical device intended to be used in conjunction with a standard plunger syringe and needle to administer an injection of medication or vaccine to a patient intramuscularly (IM) and/or subcutaneously; it is not intended for intradermal injection. The delivered medication/vaccine is supplied from the prefilled syringe that is loaded into the injector, which is typically a spring-loaded mechanical assembly. It is intended for use by a healthcare professional when serial injections are provided (e.g., mass inoculation); it is not a hypodermic syringe. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature20 Degrees Fahrenheit130 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
5625462811bobby@syringepro.com

Regulatory Flags

DUNS number
074078018
Device count
20
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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06974405097320CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
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