Identity
- Trade Name
- Lid implant (lid chain) FDA UDI
- Generic Name
- Eyelid weight, implantable FDA UDI
- Device Name
- Lid implant (lid chain) Platinum/Iridium according to Berghaus/Schrom, 1.2 g, sterile, 1 piece FDA UDI
- Model / Reference
- 1500-12 FDA UDI
- Description
- Lid implant (lid chain) Platinum/Iridium according to Berghaus/Schrom, 1.2 g, sterile, 1 piece FDA UDI
Identifiers
- Catalog Number
- 1500-12 FDA UDI
- Primary DI / UDI-DI
- 04250381807224 FDA UDI
- 510(k) Number
- K021750 FDA UDI
- FDA Product Code
- MML FDA UDI
- GMDN Term
- Eyelid weight, implantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.5700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Weight — 1.2 Gram FDA UDI
Category: Eyelid weight, implantable
Lid implant (lid chain) by Spiggle & Theis Medizintechnik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Eyelid weight, implantable.
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Cleared under the same submission
K021750 also covers:
- Berghaus/Schrom — JEDMED Instrument Company
- Berghaus/Schrom — JEDMED Instrument Company
- Berghaus/Schrom — JEDMED Instrument Company
- Berghaus/Schrom — JEDMED Instrument Company
- Berghaus/Schrom — JEDMED Instrument Company
- Berghaus/Schrom — JEDMED Instrument Company
- Berghaus/Schrom — JEDMED Instrument Company
- Berghaus/Schrom — JEDMED Instrument Company
- Lid implant (lid chain) — Spiggle & Theis Medizintechnik GmbH
- Lid implant (lid chain) — Spiggle & Theis Medizintechnik GmbH
- Lid implant (lid chain) — Spiggle & Theis Medizintechnik GmbH
- Lid implant (lid chain) — Spiggle & Theis Medizintechnik GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Spiggle & Theis Medizintechnik GmbH
Sources (1)
- FDA UDI 243e1109-5cf7-4dd8-bb4e-336a61614bf8 38 fields · synced May 30, 2026