Identity
- Trade Name
- Robotic Suture Hook Left FDA UDI
- Generic Name
- Ligature loop applier FDA UDI
- Device Name
- Suture Hook with Left curl FDA UDI
- Model / Reference
- RSH-L FDA UDI
- Description
- Suture Hook with Left curl FDA UDI
Identifiers
- Primary DI / UDI-DI
- B040RSHL0 FDA UDI
- FDA Product Code
- DWS FDA UDI
- GMDN Term
- Ligature loop applier FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.4500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Ligature loop applier
Robotic Suture Hook Left by Genesee Biomedical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ligature loop applier.
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- BOSS Instruments — Boss Instruments, Ltd. · Class I
- Robotic Suture Hook Right — GENESEE BIOMEDICAL, INC. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Genesee Biomedical, Inc.
Sources (1)
- FDA UDI 99ded987-f67d-42e3-94fe-7bf85b0b7185 33 fields · synced May 29, 2026