AccessGUDID - DEVICE: Green Sprouts (00715418163413)

GUDID

Device Identifier (DI) Information

Brand Name: Green Sprouts
Version or Model: 385372-200-33
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: O2cool, LLC

Primary DI Number: 00715418163413
Issuing Agency: GS1
Commercial Distribution End Date: June 01, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 004603413 *Terms of Use

Device Description: First Teethers made from Silicone (3pk)-Pink Set-3mo+

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":	Yes
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?
44258	Teething device, non-fluid-filled	A circular or cylindrical device free of fluid and intended to be bitten by a patient (infant or adult) to soothe gums during the teething process. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MEF	Ring, Teething, Non-Fluid Filled

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: d28afd33-050b-43e4-b3c7-36106b4bd0b1
Public Version Date: December 08, 2023
Public Version Number: 2
DI Record Publish Date: June 01, 2021

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

Customer Contact

[?]

No Customer Contact currently defined

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