AccessGUDID - DEVICE: Plenity™ (10860517002631)

GUDID

Device Identifier (DI) Information

Brand Name: Plenity™
Version or Model: MC0420
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GELESIS, INC.

Primary DI Number: 10860517002631
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 14
Labeler D-U-N-S® Number*: 010729307 *Terms of Use

Device Description: Super-absorbent hydrogel to aid in weight management.

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?
48146	Ingested gastric satiety device	An orally-administered device intended to facilitate weight loss and treat obesity through appetite control. It is designed to be swallowed before meals to form a viscous gel in the stomach and/or small intestine to increase distention, creating the sensation of fullness and causing the user to eat less. It may additionally slow down intestinal glucose absorption to improve glycaemic control. It typically includes natural or modified fibre which expands after absorbing water; it is available in tablet, capsule, and powder sachet forms. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QFQ	Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN180060	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
Storage Environment Temperature: between 5 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: eaef4497-f72c-4b53-9ebe-d5b388f10b0b
Public Version Date: May 14, 2020
Public Version Number: 1
DI Record Publish Date: May 06, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00860517002641	4	10860517002631		In Commercial Distribution	Monthly Kit

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00860517002634 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: 1-844-753-6489
Email: info@gelesis.com

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