FDA UDI
In Commercial Distribution
🇺🇸 United States
Flexor Tendon Sheath Retractor and Suture Retriever / Sheath Dilator
DI: 00816101010004
·
Model: NA
·
TOBY ORTHOPAEDICS
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Flexor Tendon Sheath Retractor and Suture Retriever / Sheath Dilator
- Primary DI
- 00816101010004
- Version / Model
- NA
- Catalog Number
- TO-FTRT
- Company Name
- TOBY ORTHOPAEDICS
- Labeler DUNS
- 024163331
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-22
- Public Version
- 1
- Public Version Date
- 2026-04-30
- Public Version Status
- New
- Public Device Record Key
- 89fe511c-8c7d-41de-b9f7-dd36776244b2
Device Description
The Flexor Tendon Sheath Retractor and Suture Retriever/ Sheath Dilator device, also referred to as the FTRT device, includes a sheath dilator tool and a transparent funnel-sheath retractor tool, that are to be used in surgical procedures that aim to repair lacerated digital flexor tendons.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAD | Retractor | General, Plastic Surgery | 878.4800 | 1 |
| HWQ | Passer | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17674 | Tendon approximator | One of a pair or set of surgical instruments used to grasp the torn or resected portions of a tendon to hold the portions in apposition for the purpose of reattaching one portion to the other in order to repair the structure. Also, an instrument used to grasp a tendon, or separated parts of a tendon, to position it in a surgical opening. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816101010004 | GS1 |