AccessGUDID - DEVICE: DynaMag™ 16-2mL Tube Dx (10190302006002)

GUDID

Device Identifier (DI) Information

Brand Name: DynaMag™ 16-2mL Tube Dx
Version or Model: A31346
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LIFE TECHNOLOGIES CORPORATION

Primary DI Number: 10190302006002
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080131636 *Terms of Use

Device Description: DYNAMAG 16-2ML DX

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):	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?
60115	Magnetic cell separation magnet	A device featuring a permanent magnet designed to be used for the magnetic separation of specific cell types or subpopulations from heterogeneous human cell preparations. It typically functions in combination with a magnetizing reagent and buffered solution to separate the target cell population by retention in a magnetic field. This device is typically used in regenerative and in vitro fertilization (IVF)/assisted reproduction technique (ART) medicine, or during diagnostic testing of specific cell populations to support diagnosis of certain conditions. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PFT	Reagents for molecular diagnostic test systems

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: 145be55d-243f-4947-969a-9947fb3df563
Public Version Date: June 04, 2024
Public Version Number: 5
DI Record Publish Date: June 26, 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
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: Yes
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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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