FDA UDI
In Commercial Distribution
🇺🇸 United States
CastleLoc Pectus Bar System
DI: 08809986461711
·
Model: PB28-1150
·
L&K BIOMED CO. ,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CastleLoc Pectus Bar System
- Primary DI
- 08809986461711
- Version / Model
- PB28-1150
- Company Name
- L&K BIOMED CO. ,LTD.
- Labeler DUNS
- 631159324
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-07
- Public Version
- 1
- Public Version Date
- 2025-03-17
- Public Version Status
- New
- Public Device Record Key
- b8fe591a-a056-4a1f-9871-201232996a60
Device Description
CastleLoc Pectus Bar – Curved 1
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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| HRS | Plate, Fixation, Bone | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61522 | Funnel chest remodelling bar | A non-sterile implantable device intended to be used to reduce the deformity of pectus excavatum (funnel chest) by applying outward force from a position deep to the sternum to reposition the sternum; it is typically used in paediatric patients and surgically removed when remodelling is evident (after 2-3 years). It is a thin curved bar, with or without serrations, made of metal [e.g., stainless steel, titanium (Ti)] that can be anchored with wires or with stabilizer plates laterally on the rib cage. This is a single-patient device intended to be sterilized prior to use. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809986461711 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243357 | 000 |