AccessGUDID - DEVICE: Molded Products, Inc. (B144MPC9501)

GUDID

Device Identifier (DI) Information

Brand Name: Molded Products, Inc.
Version or Model: MPC-950
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MPC-950
Company Name: MOLDED PRODUCTS, INC.

Primary DI Number: B144MPC9501
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 157506015 *Terms of Use

Device Description: The E-Z Grip. A lightweight tool for help with gripping and grabbing.

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?
64363	Assistive gripping/twisting tool, reusable	A hand-held manual device intended to be used to grip and/or twist medical device and/or household items, usually to lock/unlock, turn on and off, and/or open and close components. It may or may not be intended to be a disability-assistive tool and it might have one or more gripping component(s) or spanner-like ends, and a lever or dial for twisting/turning. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKW	Utensil, Homemaking

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: 6990ed3f-6b50-4e53-af9b-ad6b2779d4ab
Public Version Date: June 14, 2023
Public Version Number: 1
DI Record Publish Date: June 06, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
B144MPC9503	100	B144MPC9501		In Commercial Distribution	Case

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

Customer Contact

[?]

No Customer Contact currently defined

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