AccessGUDID - DEVICE: EDM (00763000030148)

GUDID

Device Identifier (DI) Information

Brand Name: EDM
Version or Model: 27659
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC PS MEDICAL, INC.

Primary DI Number: 00763000030148
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 089055867 *Terms of Use

Device Description: EDM 27659 V/CATHETER 20CM LENGTH MARKER

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
61399	Intracerebral infusion/drainage catheter, short-term	A flexible tube intended to be surgically inserted through the skull for short-term (= 30 days) subdural access to the brain (e.g., cerebral ventricles, cystic tumours) for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents); it may also be intended for measurement of intracranial pressure (ICP). It may include an attached port/reservoir at its proximal end that is placed subcutaneously to facilitate material infusion/collection, and/or accessory devices intended to facilitate catheter introduction and/or stabilization (e.g., stylet, bolts, drills, catheter holder); it does not include a sensor. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWM	Device, monitoring, intracranial pressure

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K802100	000

Device Exempt from Premarket Submission: No 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
No Device Sizes

Device Record Status

Public Device Record Key: 47a31ded-58e8-45df-902e-a2c64d7b014a
Public Version Date: October 17, 2022
Public Version Number: 3
DI Record Publish Date: May 08, 2020

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

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: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)633-8766
Email: Corporate.UDI@medtronic.com

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