AccessGUDID - DEVICE: EZ-Squeeze (05060488047251)

GUDID

Device Identifier (DI) Information

Brand Name: EZ-Squeeze
Version or Model: 145µm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7-72-3145/20
Company Name: Coopersurgical, Inc.

Primary DI Number: 05060488047251
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 801895244 *Terms of Use

Device Description: Assisted Reproduction Microtools (Pipettes)

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?
56553	HLA class II antibody identification panel IVD, kit, multiplex	A collection of reagents and other associated materials intended to be used for the identification of one or multiple antibodies to HLA class II antigens in a clinical specimen, using solid phase antigens together with a multiplex method.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MQH	Microtools, Assisted Reproduction (Pipettes)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161275	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: 92aa0d45-df49-409f-bc36-02f0da2f4b90
Public Version Date: April 21, 2025
Public Version Number: 1
DI Record Publish Date: April 11, 2025

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

Customer Contact

[?]

Phone: 4546790202
Email: rira@coopersurgical.com

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