Model: SPK4709PK
Catalog: SPK4709PK
DI: 00757770535583
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
POST-OP GOGGLES PROCEDURAL PK
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
faac5081-76b9-42c7-b352-a9af44936151
Distribution Status:
In Commercial Distribution
DUNS Number:
196603781
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00757770535583
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 65733
Name: Postsurgical eye shield, vented
Definition:
A device designed to be worn over the eye to protect the eye following ophthalmic surgery; some types may in addition be used following injury/trauma. It is designed as a transparent or opaque dome with vent holes to allow air to circulate around the eye; it may be self-adhesive, or fixed by a strap or an adhesive dressing. This is a single-use device.
FDA Product Codes
HOY
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)