Wedge

Basic Information

• Brand Name: Wedge
• Primary DI: 10871321001925
• Version / Model: S 3022
• Company Name: Labtician Ophthalmics, Inc
• Labeler DUNS: 248911026
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2015-10-09
• Public Version: 5
• Public Version Date: 2021-12-22
• Public Version Status: Update
• Public Device Record Key: 93a1fbdc-8617-447c-b9d3-0453d119a1d6

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: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
HQJ	Implant, Absorbable, (Scleral Buckling Methods)	Ophthalmic	886.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
15794	Scleral buckling device, bioabsorbable	A bioabsorbable device intended to be implanted on the sclera to compress the eye (scleral buckling) for the surgical treatment of retinal detachment.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10871321001925	GS1
Unit of Use	00871321000785	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K875014	000