BOVIE 0002

GUDID 10607151000025

EYE BUBBLE

BOVIE MEDICAL CORPORATION

Eye mask

• Primary Device ID: 10607151000025
• NIH Device Record Key: 66d2da51-c048-4e02-8a5a-d8cf482dec79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BOVIE
• Version Model Number: 0002
• Catalog Number: 0002
• Company DUNS: 079940465
• Company Name: BOVIE MEDICAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607151000028 [Primary]
GS1	10607151000025 [Package]; Contains: 00607151000028; Package: BOX [10 Units]; In Commercial Distribution

FDA Product Code

• HOY: Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-10

On-Brand Devices [BOVIE]

• 10607151786967: VACUUM HOSE 7/8" (2.22cm) X 6' (1.8288m) WITH HOSE TO HOSE CONNECTOR
• 10607151710115: REPLACEABLE FINE TIP WITH ADHESIVE
• 10607151659360: VACUUM HOSE 7/8" (2.2225 cm) X 6' (1.8288m) WITH WAND & SPONGE GUARD
• 10607151653368: REDUCER FITTING 7/8" (2.22CM) TO ¼" (.63CM) WITH 24” (60.96CM) MEDICAL (PVC) TUBING
• 00607151563783: DISPOSABLE ELECTROSURGICAL FOOT CONTROL PENCIL W/ HOLSTER & SCRATCH PAD
• 10607151563773: DISPOSABLE FOOT CONTROL PENCIL WITH SS BLADE AND HOLSTER
• 10607151563681: DISPOSABLE ROCKER SWITCH PENCIL WITH BOVIE'S NEEDLE
• 10607151563674: DISPOSABLE ELECTROSURGICAL ROCKER PENCIL WITH HOLSTER
• 10607151563537: DISPOSABLE SPLIT ADULT RETURN ELECTRODE WITH CABLE
• 00607151563189: DISPOSABLE PUSH BUTTON PENCIL WITH BOVIE'S NEEDLE
• 10607151563179: DISPOSABLE ELECTROSURGICAL PENCIL WITH HOLSTER
• 00607151112035: FOOTSWITCH A1200
• 00607151086152: SURCH-LITE ™ MEDICAL LIGHT NON-STERILE 15'' (38.1cm)
• 00607151086107: SURCH-LITE ™ MEDICAL LIGHT NON-STERILE 10'' (25.4cm)
• 00607151086053: SURCH-LITE ™ MEDICAL LIGHT NON-STERILE 5'' (12.5cm)
• 00607151073916: POWER HANDLE HIGH-TEMP
• 00607151073909: POWER HANDLE LOW-TEMP
• 10607151071636: DISPOSABLE SHEATH FOR REPLACEABLE CAUTERY
• 10607151071216: REPLACEABLE ELONGATED TIP
• 10607151071124: REPLACEABLE 6'' FINE TIP
• 10607151071117: REPLACEABLE CIRCULAR TIP
• 10607151071100: REPLACEABLE CONTRA ANGLE FINE TIP
• 10607151071094: REPLACEABLE 5'' LOOP TIP
• 10607151071063: REPLACEABLE 2'' FLEX FINE TIP
• 00607151071059: REPLACEABLE 2'' FLEX LOOP TIP
• 10607151071049: REPLACEABLE FINE TIP ELONGATED
• 10607151071032: REPLACEABLE LOOP TIP
• 10607151071018: REPLACEABLE FINE TIP
• 10607151071001: REPLACEABLE LOW-TEMP FINE TIP
• 10607151069152: SURCH-LITE ™ SURGICAL LIGHT 15'' (38.1cm)
• 10607151069107: SURCH-LITE ™ SURGICAL LIGHT 10'' (25.4cm)
• 10607151069053: SURCH-LITE ™ SURGICAL LIGHT 5'' (12.7cm)
• 10607151065932: VACUUM HOSE 7/8" (2.2225 cm) X 6' (1.8288m) WITH WAND & SPONGE GUARD
• 10607151065338: SMOKE EVACUATOR LASER RESISTANT WAND 7/8" X 8" (3 PER POUCH)
• 10607151063396: SURCH-LITE ™ OROTRACHEAL LIGHTED INTUBATION STYLET 16" (40CM)
• 10607151056633: DISPOSABLE ELECTROSURGICAL SCRATCH PAD
• 10607151056558: STANDARD BLADE 4''
• 10607151056541: MODIFIED BLADE 4''
• 10607151056534: LLETZ LOOP ELECTRODE (15MM X 12MM)
• 10607151056527: LLETZ LOOP ELECTRODE (10MM X 8MM)
• 10607151056510: LLETZ LOOP ELECTRODE (13MM X 8MM)
• 10607151056503: BALL ELECTRODE (1/8" BALL)
• 10607151056497: LLETZ LOOP ELECTRODE (20MM X 10MM)
• 10607151056480: LLETZ LOOP ELECTRODE (10MM X 3MM)
• 10607151056473: LLETZ LOOP ELECTRODE (25MM X 10MM)
• 10607151056466: LLETZ LOOP ELECTRODE (10MM X 5MM)
• 10607151056459: LLETZ LOOP ELECTRODE (13MM X 13MM)
• 10607151056442: LLETZ LOOP ELECTRODE (15MM X 5 MM)
• 10607151056435: LLETZ LOOP ELECTRODE (15MM X 15MM)
• 10607151056428: LLETZ LOOP ELECTRODE (20MM X 12MM)