AccessGUDID - DEVICE: Scleral Shell (B863E661089V2627)

GUDID

Device Identifier (DI) Information

Brand Name: Scleral Shell
Version or Model: V2627
Commercial Distribution Status: In Commercial Distribution
Catalog Number: E661089
Company Name: TEXAS EYE PROSTHETICS LLC

Primary DI Number: B863E661089V2627
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 016863467 *Terms of Use

Device Description: No description.

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?
34000	Scleral shell	A custom-made prosthesis (a flush-fitting shell) that is used as a cosmetic artificial eye to cover a deformed or disfigured/unsightly blind eye, or over an eviscerated globe. It is made to suit a specific patient/user and will have the cosmetic representation to match the user's contra lateral real eye. It will be worn while the user is in public and normal waking hours. This is reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HQT	Shell, Scleral

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
Storage Environment Temperature: between 32 and 110 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b1e08264-8e1d-4e06-b86e-316ce0717db3
Public Version Date: April 22, 2020
Public Version Number: 1
DI Record Publish Date: April 14, 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
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: 7135241001
Email: texaseyepros@gmail.com

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