FDA.report

Marketlab Inc

Primary DI
00817517020137
Brand
Marketlab Inc
Company
MARKETLAB INC.
Model
14726
Catalog number
14726
Device description
Monoject(tm) SmarTip(tm) Ndleless Vial Access Cannula PK/100
Published
2018-11-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GEACANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817517020137PrimaryGS10
00817517021004Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817517020137008175170201378175170201370817517020137
00817517021004008175170210048175170210040817517021004

GMDN Terms

TermDefinition
Medicine preparation needle/cannula, non-sterileA non-sterile slender metallic or plastic tube with a blunt distal end intended to be attached to a syringe in order to aspirate pharmaceutical fluids from vials or ampules during the preparation of some medications performed by healthcare professionals (e.g., pharmacists, physicians, nurses). This device is not intended for skin injections or tissue manipulation. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(866) 237-3722service@marketlabinc.com

Regulatory Flags

DUNS number
848917027
Device count
100
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00817517028072Marketlab-Clinton1387712024-02-02
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00817517028096Marketlab-Clinton1387732024-02-02
00817517028102Marketlab-Clinton1387742024-02-02
00817517028119Marketlab-Clinton1387752024-02-02
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00817517028157Marketlab-Clinton1387792024-02-02
00817517028164Marketlab-Clinton1387802024-02-02
00817517028171Marketlab-Clinton1387812024-02-02

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