AccessGUDID - DEVICE: Bovie (00887482176795)

GUDID

Device Identifier (DI) Information

Brand Name: Bovie
Version or Model: 0010
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SYMMETRY SURGICAL INC.

Primary DI Number: 00887482176795
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079641356 *Terms of Use

Device Description: Burr; Opthalmic II; Power Handle

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):	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?
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
HOG	Burr, Corneal, Battery-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K950520	000

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between 10 and 30 Degrees Celsius
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a6320f57-92ca-4f1f-bf1f-bda998a73e69
Public Version Date: June 04, 2025
Public Version Number: 2
DI Record Publish Date: August 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: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1 888-364-7004
Email: customerservice@symmetrysurgical.com

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