FDA UDI
In Commercial Distribution
🇺🇸 United States
ReConnex™
DI: M536PST17090
·
Model: PST17090
·
ALLOSOURCE
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ReConnex™
- Primary DI
- M536PST17090
- Version / Model
- PST17090
- Catalog Number
- PST17090
- Company Name
- ALLOSOURCE
- Labeler DUNS
- 946808136
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-15
- Public Version
- 1
- Public Version Date
- 2018-09-17
- Public Version Status
- New
- Public Device Record Key
- e86edfe5-c3cd-4ee5-b846-a79b9063798c
Device Description
ReConnex™ Pre-Sutured Tendon
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- Yes
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | 878.5000 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60501 | Tendon graft | A sterile tendon tissue, which may include a bone block, intended for transplantation that is harvested from a human donor. The tissue is intended to be used to replace or strengthen damaged tendon in any part of the human body. It may include non-tissue components (e.g. suture) to facilitate its implantation or function. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M536PST17090 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170957 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 9 | Millimeter | |
| Length | 70 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – -40 Degrees Celsius