DEVICE: Marketlab Inc (00817517020137)

Device Identifier (DI) Information

Marketlab Inc
14726
In Commercial Distribution
14726
MARKETLAB INC.
00817517020137
GS1

100
848917027 *Terms of Use
Monoject(tm) SmarTip(tm) Ndleless Vial Access Cannula PK/100
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
62589 Medicine preparation needle/cannula, non-sterile
A 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.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
GEA CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

fbbb0dad-54e7-42a0-a1c6-7cf834b5575b
December 17, 2018
1
November 16, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 00817517021004 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(866) 237-3722
service@marketlabinc.com
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