David-Baker,Stainless Steel Lid Clamp for the Laser, regular (non glare)

Basic Information

• Brand Name: David-Baker,Stainless Steel Lid Clamp for the Laser, regular (non glare)
• Primary DI: 10697660002221
• Version / Model: 21-323
• Company Name: Oculo-Plastik Inc
• Labeler DUNS: 257382580
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-18
• Public Version: 2
• Public Version Date: 2022-12-08
• Public Version Status: Update
• Public Device Record Key: 105270a4-4725-4d92-91d4-0b8bb59867a2

Device Description

The easy-to-use David-Baker Retractors feature a simple, curved clamping mechanism to gently retract the upper eyelid while protecting sensitive scleral membranes.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32775	Eyelid clamp, reusable	A hand-held manual surgical instrument designed specifically to atraumatically grasp and hold the eyelid or isolate a portion of eyelid tissue during an ophthalmic surgical intervention (e.g., chalazion surgery, blepharostoplasty). It includes an appropriate clamping mechanism which may be one of a variety of designs (e.g., ring and disk), and may be referred to as entropion forceps, Downes lid clamp, or chalazion clamp. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10697660002221	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Width	32	Millimeter