AccessGUDID - DEVICE: Lamaze (B268Y5288L0)

GUDID

Device Identifier (DI) Information

Brand Name: Lamaze
Version or Model: Y5228L
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TOMY INTERNATIONAL, INC.

Primary DI Number: B268Y5288L0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 065183758 *Terms of Use

Device Description: Teether

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?
44272	Teething device, fluid-filled	A circular or cylindrical device filled with fluid (e.g., water) 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
KKO	Ring, Teething, 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: 9d1a10a5-8ae0-4ae9-8708-ee8dc2cabd4e
Public Version Date: October 21, 2019
Public Version Number: 1
DI Record Publish Date: October 11, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
B268Y5288L9	4	B268Y5288L6	In Commercial Distribution	Master Carton
B268Y5288L6	6	B268Y5288L1	In Commercial Distribution	Inner Carton
B268Y5288L1	1	B268Y5288L0	In Commercial Distribution	Retail Package

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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