AccessGUDID - DEVICE: Bausch + Lomb (00757770407712)

GUDID

Device Identifier (DI) Information

Brand Name: Bausch + Lomb
Version or Model: X0750 21
Commercial Distribution Status: In Commercial Distribution
Catalog Number: X0750 21
Company Name: Bausch & Lomb Incorporated

Primary DI Number: 00757770407712
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 196603781 *Terms of Use

Device Description: FENEST'TR GUILFRD-WGHT NEW ANG

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):	Yes
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?
65499	Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to DNAse B enzyme produced by Group A beta-haemolytic Streptococcus bacteria in a clinical specimen, using a nephelometry/turbidimetry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JYO	Knife, Ear

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: eabe8e95-e339-44ae-bd30-29140849e98f
Public Version Date: August 13, 2025
Public Version Number: 1
DI Record Publish Date: August 05, 2025

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

Customer Contact

[?]

No Customer Contact currently defined

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