AccessGUDID - DEVICE: EZ-Grip (05060170181690)

GUDID

Device Identifier (DI) Information

Brand Name: EZ-Grip
Version or Model: EZ-Grip
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7-72-2800
Company Name: RESEARCH INSTRUMENTS LIMITED

Primary DI Number: 05060170181690
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 536139413 *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:	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?
46553	Assisted reproduction microtool	A dedicated pipette or other device used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods. This is a single-use device.	Active	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: 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: dcf703e4-4102-4c37-aa37-30d3c4324204
Public Version Date: February 28, 2024
Public Version Number: 4
DI Record Publish Date: December 22, 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: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 4546790202
Email: origio@origio.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES