AccessGUDID - DEVICE: Leukoplast® (04042809687514)

GUDID

Device Identifier (DI) Information

Brand Name: Leukoplast®
Version or Model: 76466-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 76466-00
Company Name: BSN medical GmbH

Primary DI Number: 04042809687514
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 30
Labeler D-U-N-S® Number*: 342651662 *Terms of Use

Device Description: LEUKOPLAST EYE OCCLUSOR 5.5CM X 7.6CM REGULAR TAN 30 HOSP

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):	No
Over the Counter (OTC):	Yes
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
HMP	PAD, EYE

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
Width: 5.5 Centimeter
Length: 7.6 Centimeter

Device Record Status

Public Device Record Key: 77a61199-40bd-4ff8-8fd0-1a55c28c5086
Public Version Date: October 12, 2023
Public Version Number: 2
DI Record Publish Date: December 08, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
04042809687521	12	04042809687514		In Commercial Distribution

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 04042809687538 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(800)537-1063
Email: HMS.ORDERS@ESSITY.COM

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES