BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

BOVIE

DI: 00607151000028 · Model: 0002 · ASPEN SURGICAL PRODUCTS, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

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Basic Information

Brand Name: BOVIE
Primary DI: 00607151000028
Version / Model: 0002
Catalog Number: 0002
Company Name: ASPEN SURGICAL PRODUCTS, INC.
Labeler DUNS: 027680821
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-10-10
Public Version: 3
Public Version Date: 2025-12-30
Public Version Status: Update
Public Device Record Key: 66d2da51-c048-4e02-8a5a-d8cf482dec79

Device Description

EYE BUBBLE

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: Yes
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	886.4750	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35063	Eye mask	A mechanical shield intended to be fitted over the eyes to prevent the intrusion of light, typically to facilitate rest or sleep in illuminated environments and/or at home. It typically consists of an external covering made of an opaque plastic, or other appropriate material, that does not allow the passage of light and that is lined with a padded inner liner (e.g., foam, gauze); it is held in place with a strap(s). It is intended for single-patient use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10607151000025	GS1	BOX	10	In Commercial Distribution
Primary	00607151000028	GS1

Storage Conditions

Type: Storage Environment Humidity
Temperature Range: 10 – 75 Percent (%) Relative Humidity
Type: Storage Environment Temperature
Temperature Range: 10 – 30 Degrees Celsius