PURE PECTUS
- Primary DI
- 00888118143341
- Company
- KLS-Martin L.P.
- Model
- 24-071-44-09
- Device description
- PECTUS BAR, ANGLED, CP TITANIUM
- Published
- 2026-03-23
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Regulatory Flags
- DUNS number
- 826499238
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00888118143341 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 00888118143341 | Primary | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| HRS | Plate, Fixation, Bone | 2 | Orthopedic | 888.3030 | Y | Eligible |
Premarket Submissions
No records found.
Premarket Details
No records found.
GMDN Terms
| Term | Definition |
|---|
| 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. |
Device Sizes
| Type | Value | Text |
|---|
| Device Size Text, specify | 0 | 44 CM |
Storage And Handling
No records found.
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts
| Phone | Email |
|---|
| +1(904)641-7746 | KLS-UDI-Info@klsmartin.com |
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00888118143266 | PURE PECTUS | KLS-Martin L.P. | HRS | 2026-03-23 |
| 00888118143273 | PURE PECTUS | KLS-Martin L.P. | HRS | 2026-03-23 |
| 00888118143280 | PURE PECTUS | KLS-Martin L.P. | HRS | 2026-03-23 |
| 00888118143297 | PURE PECTUS | KLS-Martin L.P. | HRS | 2026-03-23 |
| 00888118143303 | PURE PECTUS | KLS-Martin L.P. | HRS | 2026-03-23 |
| 00888118143310 | PURE PECTUS | KLS-Martin L.P. | HRS | 2026-03-23 |
| 00888118143327 | PURE PECTUS | KLS-Martin L.P. | HRS | 2026-03-23 |
| 00888118143334 | PURE PECTUS | KLS-Martin L.P. | HRS | 2026-03-23 |
| 00888118143358 | PURE PECTUS | KLS-Martin L.P. | HRS | 2026-03-23 |
| 00888118143365 | PURE PECTUS | KLS-Martin L.P. | HRS | 2026-03-23 |
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