AccessGUDID - DEVICE: MYELO-NATE (H67140115150)

GUDID

Device Identifier (DI) Information

Brand Name: MYELO-NATE
Version or Model: Procedure Kit
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4011515
Company Name: UTAH MEDICAL PRODUCTS, INC.

Primary DI Number: H67140115150
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 094651270 *Terms of Use

Device Description: MYELO-NATE KIT 25GA 1"NDL

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":	Yes
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?
12404	Lumbar puncture kit	A collection of devices intended for transient percutaneous access to the subarachnoid (intrathecal) or epidural space of the lumbar spinal column to obtain a sample of cerebrospinal fluid (CSF). Typical components include a spinal needle and collection tubes for the CSF; a drainage catheter is not included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDD	Kit, Surgical Instrument, Disposable

FDA Premarket Submission

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

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: cce541f4-80bb-45e1-9e98-7267489f1fd8
Public Version Date: December 23, 2024
Public Version Number: 2
DI Record Publish Date: June 04, 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
H67140115151	10	H67140115150		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: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 800-533-4984
Email: customer@utahmed.com

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