AccessGUDID - DEVICE: Intro (08052440106349)

GUDID

Device Identifier (DI) Information

Brand Name: Intro
Version or Model: PT15110
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PT15110
Company Name: M.D.L. S.R.L.

Primary DI Number: 08052440106349
Issuing Agency: GS1
Commercial Distribution End Date: May 14, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 447228586 *Terms of Use

Device Description: 10 CS - COAXIAL INTRODUCER NEEDLE 15GX110mm

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62257	Orthopaedic coaxial injection applicator	A tubular device with a concentric dual-lumen and a plunger intended to be used during surgery for the percutaneous injection of therapeutic materials (e.g., biologics, bone void fillers, irrigation fluids) into a bone, having been passed over a guidewire to the injection site. Typically, the inner lumen is used for the guidewire and the outer lumen for injection of fluids aided by the plunger. The device is made of metal and/or polymer materials. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MJG	Device, Percutaneous, Biopsy

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 15 Gauge
Length: 110 Millimeter

Device Record Status

Public Device Record Key: 8eb5235b-1c38-403c-9f57-d4c34e598ba6
Public Version Date: May 27, 2021
Public Version Number: 9
DI Record Publish Date: February 20, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
08052440108985	10	08052440106349	2021-05-14	Not in Commercial Distribution

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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