AccessGUDID - DEVICE: METALS LEVEL 2 (B80001696000040)

GUDID

Device Identifier (DI) Information

Brand Name: METALS LEVEL 2
Version or Model: MET T 2 DP UK
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: UTAK LABORATORIES, INC.

Primary DI Number: B80001696000040
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 092519016 *Terms of Use

Device Description: METALS LEVEL 2

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:	No
Prescription Use (Rx):	No
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?
54714	Multiple heavy metal IVD, control	A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple heavy metals in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LAS	Drug Specific Control Materials

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: No
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: 270c7f94-e6aa-4877-9e2d-cb7496cd40eb
Public Version Date: August 18, 2022
Public Version Number: 1
DI Record Publish Date: August 10, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
B80001696000041	4	B80001696000040	In Commercial Distribution	Box
B80001696000042	5	B80001696000040	In Commercial Distribution	Box
B80001696000043	10	B80001696000040	In Commercial Distribution	Box
B80001696000046	25	B80001696000040	In Commercial Distribution	Box
B80001696000047	50	B80001696000040	In Commercial Distribution	Box
B80001696000048	100	B80001696000040	In Commercial Distribution	Box

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: +1(888) 882-5522
Email: welovecontrol@utak.com

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