AccessGUDID - DEVICE: Bernell (B945TLRSP7000)

GUDID

Device Identifier (DI) Information

Brand Name: Bernell
Version or Model: TLRS+7.00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TLRS+7.00
Company Name: Bernell

Primary DI Number: B945TLRSP7000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 175947340 *Terms of Use

Device Description: Trial Lens Replacement Spherical +7.00

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):	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?
34653	Vision corrective trial lens	A non-patient-contact ophthalmic trial lens, or set of trial lenses of various dioptric powers, intended for vision testing to determine the required refraction for vision correction. This device may be used in conjunction with a phoropter (not included).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HPC	Set, Lens, Trial, Ophthalmic

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: 2779d417-5ea0-4cc7-918a-d0005c3389e5
Public Version Date: May 11, 2026
Public Version Number: 1
DI Record Publish Date: May 03, 2026

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

[?]

No Customer Contact currently defined

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