Lid implant (lid chain)

Basic Information

• Brand Name: Lid implant (lid chain)
• Primary DI: 04250381807262
• Version / Model: 1500-20
• Catalog Number: 1500-20
• Company Name: Spiggle & Theis Medizintechnik GmbH
• Labeler DUNS: 332893028
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-11-08
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 108776ae-a506-4d1c-a897-0a1c59dcd260

Device Description

Lid implant (lid chain) Platinum/Iridium according to Berghaus/Schrom, 2.0 g, sterile, 1 piece

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 Conditional
• 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
MML	Weights, Eyelid, External	Ophthalmic	886.5700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
18074	Eyelid weight, implantable	An ophthalmic device that is implanted subcutaneously within the upper eyelid to "lidload" the eyelid to restore upper eyelid muscle (musculus orbicularis oculi) function. This device is used for the treatment of lagophthalmos, a condition that frequently results from facial paralysis caused by Bell's palsy, trauma, a stroke, or as an indirect consequence of the surgical removal of certain types of tumour in close proximity to the facial nerve. This device uses gravity to gently close the upper eyelid when blinking or when the eyelid muscle is relaxed, and is made of a heavy material [e.g., gold (Au), platinum (Pt)].	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04250381807262	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K021750	000

Device Sizes

Type	Value	Unit	Text
Weight	2.0	Gram

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Storage must protect from dust, moisture and contamination. Avoid direct sunlight during storage.