Identity
- Trade Name
- Skytron Split Leg FDA UDI
- Generic Name
- Leg procedure positioner FDA UDI
- Device Name
- Carbon fiber split leg positioner device which allows for mid-line access to the patient with controls to independently adjust the legs for full abduction/adduction as well as positioning to high lithotomy. Ideal for Laparoscopic and orthopedic procedures. FDA UDI
- Model / Reference
- 4-030-70 FDA UDI
- Description
- Carbon fiber split leg positioner device which allows for mid-line access to the patient with controls to independently adjust the legs for full abduction/adduction as well as positioning to high lithotomy. Ideal for Laparoscopic and orthopedic procedures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810105030631 FDA UDI
- FDA Product Code
- BWN FDA UDI
- GMDN Term
- Leg procedure positioner FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4950 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Leg procedure positioner
Skytron Split Leg by Composite Manufacturing, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Composite Manufacturing, Inc.
Sources (1)
- FDA UDI 39a1c54b-e3e2-4db4-bfe7-5743bbb0b731 33 fields · synced May 29, 2026