AccessGUDID - DEVICE: Visitec® (30886158002254)

GUDID

Device Identifier (DI) Information

Brand Name: Visitec®
Version or Model: 581019
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 581019
Company Name: Beaver-Visitec International, Inc.

Primary DI Number: 30886158002254
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001406024 *Terms of Use

Device Description: SHIELD EYE LEFT/RIGHT 8.5CM (50/SP)

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?
61490	Eye patch	A device intended to be used to close/cover one or both eyes, for the purpose of protecting the eye after a procedure or as part of an ophthalmic therapeutic intervention. It is made of a synthetic or biological material. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HOY	Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)

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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in a dry place.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5a76aac8-cedc-4f4e-981f-6c28e9498475
Public Version Date: July 05, 2024
Public Version Number: 1
DI Record Publish Date: June 27, 2024

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

[?]

Phone: +1(866)906-8080
Email: customersupport@bvimedical.com

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