AccessGUDID - DEVICE: Wexler Surgical, Inc. (M944BL000440)

GUDID

Device Identifier (DI) Information

Brand Name: Wexler Surgical, Inc.
Version or Model: BL0004.4
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WEXLER SURGICAL, INC.

Primary DI Number: M944BL000440
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 024882552 *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?
46395	Corneal bur handpiece, battery-powered	A battery-powered, hand-held rotating device designed to perform corneal, and other ophthalmic tissue, abrasion through a bur attached to its distal tip. The device typically stops if the pressure on the tissue (e.g., cornea) is beyond a pre-established limit. It is used (with appropriate burs) to clean rust rings from the cornea after the extraction of a ferrous foreign object, to polish corneal scratches and/or the pterygium bed after surgical removal, and/or for abrasion of lid margin lesions. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHW	Burr, Corneal, Battery Powered, Rust Ring Removal

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: b87d4f8c-08ac-49fd-bdcd-637e055f6b5c
Public Version Date: November 23, 2021
Public Version Number: 2
DI Record Publish Date: March 02, 2018

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
GS1	00840240911335

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: 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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