DEVICE: Unifine Pentips Plus (00384702890016)

Device Identifier (DI) Information

Unifine Pentips Plus
AN 2890
In Commercial Distribution

OWEN MUMFORD USA INCORPORATED
00384702890016
GS1

90
803401454 *Terms of Use
Unifine Pentips Plus - 6mm x 31G
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
Yes
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
44127 Autoinjector needle
A device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FMI Needle, Hypodermic, Single Lumen
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K152339 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 5 and 40 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Needle Gauge: 31 Gauge
Length: 6 Millimeter
CLOSE

Device Record Status

b6bc2be7-33eb-4b8e-922c-0c0a007994e4
January 13, 2022
4
September 19, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
00384702890023 6 00384702890016 In Commercial Distribution Sleeve
00384702890030 24 00384702890023 In Commercial Distribution Case
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: 00384703890008 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
770-977-2226
info@owenmumfordinc.com
CLOSE