FDA Registration
Active
🇺🇸 United States
S.C. Head Pad D
Reg #: 1825014
·
FEI: 1825014
·
Expires 2025
Products
1
Proprietary Names
113
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Skytron, LLC
- Registration Number
- 1825014
- FEI Number
- 1825014
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5085 Corporate Exchange Blvd SE
- City
- Grand Rapids
- State
- MI
- ZIP
- 49512
- Country
- US
Owner / Operator
- Firm Name
- Skytron, LLC
- Operator Number
- 9918015
- Address
- 5085 Corporate Exchange Blvd SE, --
- City
- Grand Rapids
- State
- MI
- Postal Code
- 49512
- Country
- US
- Correspondent
- Robert - Vreeland
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Surgical Table Cushion | LWG | Class 1 | General, Plastic Surgery | No | 2015-12-09 |
Proprietary Names
S.C. Head Pad D
3" 3-piece extra wide Bariatric Sof-Pad set (3600B)
2" 3PC PAD SET: 3501B, 3501C, 3502, 3503, 3600 SERIES WELDED SEAMS
3" Sof-Pad for Transfer Board (4-030-22)
4" Sof-pad for split leg accessory (right)
2" 3PC Pad Set 1700 Welded Seam
4" 5-piece Sof-Pad set for split leg section
2" Pad for 12" carbon fiber arm surgery board
5" Sof-pad for 5" table side extension (ea.)
2" STANDARD OR RADIOLUCENT ARMBOARD PAD WELDED SEAM
4" Pads for foot rests (pr.)
3" 3PC Pad Set 1700 Welded Seam
4" pad for radiolucent & premium armboards
5" 5-piece standard pad set for split leg section
4" Pad 3000/3003 Welded Seam
2" Sof-Pad for 40" Carbon Fiber Extension
2" 3-piece extra wide Bariatric Sof-Pad set (3600B)
2" 5-piece Sof-Pad set for split leg section
3" 3PC PAD SET: 3501B, 3501C, 3502, 3503, 3600 SERIES WELDED SEAMS
4" Standard Pad for Transfer Board (4-030-22)
3" 3-3/4" 5pc. Standard Pad Set Split Leg
3" 2PC Pad Set 3100 Welded Seam
5" 3PC Pad Set 6700 Series Welded Seam
4" Sof-pad for Pelvic tilt seat
2" Sof-Pad for Carbon Fiber Armboard
2" Sof-pad for split leg accessory (left)
2" Standard Pad for Transfer Board (4-030-22)
3" 3PC Pad Set 6300 Welded Seam
2" Sof-pad for 3-1/2" table side extension (ea.)
4" Pad for narrow head section
4" 3PC Pad Set 6300 Welded Seam
4" Pad for 3-1/2" table side extension (ea.)
2" 3PC Pad Set 6002 Welded Seam
2" pad for radiolucent & premium armboards
4" 3PC PAD SET: 3501B, 3501C, 3502, 3503, 3600 SERIES WELDED SEAMS
2" Welded Seam Pad for Pivoting Carbon Fiber Armboard
3" Sof-pad for 3-1/2" table side extensions (ea.)
3" 5-piece Sof-Pad set for split leg section
Singer Starr Stacker Bariatric pad set
2" Sof Pad for Transfer Board (4-030-22)
2" Sof-pad for split leg accessory (right)
4" 3PC Pad Set 1700 Welded Seam
4" Sof-Pad for radiolucent & premium armboards
5" 5-piece Sof-Pad set for split leg section
5" 3PC Pad Set 1700 Welded Seam
5" Sof-Pad for radiolucent & premium armboards
4" Pad for 5" table side extension (ea.)
2" 5-piece standard pad set for split leg section
3" Pad 3000/3003 Welded Seam
2" Pad for 40" Carbon Fiber Extension
4" Sof-Pad for 12" carbon fiber arm surgery board
4" Welded Seam Pad for Pivoting Carbon Fiber Armboard
2" Sof-pad for 5" table side extension (ea.)
Knee crutch Sof-Pads (pr.)
5" 3PC PAD SET: 3501B, 3501C, 3502, 3503, 3600 SERIES WELDED SEAMS
4" 5-piece standard pad set for split leg section
2" Sof-pad for 10" foot extension
2" Pad 3000/3003 Welded Seam
5" Sof-Pad for 14" Bariatric Foot Extension
5" 3PC Pad Set 6002 Welded Seam
4" Welded Seam Pad 18" Foot Extension/Knee Rest
4" Sof-Pad for 14" Bariatric Foot Extension
4" 3PC Pad Set 6002 Welded Seam
3" Welded Seam Pad 18" Foot Extension/Knee Rest
3" Sof-Pad for 14" Bariatric Foot Extension
5" 2PC Pad Set 3100 Welded Seam
Standard Singer Starr Stacker
3" Standard Pad for Transfer Board (4-030-22)
5" 3PC Pad Set 6300 Welded Seam
4" Sof-pad for split leg accessory (left)
2" pad for pivoting carbon fiber armboard
4" Sof-pad for 3-1/2" table side extension (ea.)
2" 2PC Pad Set 3100 Welded Seam
4" 3PC Pad Set 6700 Series Welded Seam
4" Sof-Pad for 40" Carbon Fiber Extension
2" Pad for narrow head section
4" STANDARD OR RADIOLUCENT ARMBOARD PAD WELDED SEAM
2" Sof Pad for Split Leg Foot Rest (4-030-04)
4" Sof-Pad for Transfer Board (4-030-22)
3" STANDARD OR RADIOLUCENT ARMBOARD PAD WELDED SEAM
2" Sof-pad for foot rests (pr.)
2" 3PC Pad Set 6700 Series Welded Seam
Radiolucent standard armboard (without pad)
Carbon Fiber Armboard for 3000 and 3003 (slide under pad type)
4" Sof-pad for 5" table side extension (ea.)
4" 2PC Pad Set 3100 Welded Seam
4" Sof-pad for 10" foot extension
2" 3PC Pad Set 6300 Welded Seam
2" pad for 3-1/2" table side extension (ea.)
3" 3PC Pad Set 6002 Welded Seam
5" STANDARD OR RADIOLUCENT ARMBOARD PAD WELDED SEAM
2" Welded Seam Pad 18" Foot Extension/Knee Rest
2" Sof-Pad for 14" Bari Foot Extension
2" Sof-Pad for radiolucent & premium armboards
3" Welded Seam Pad for Pivoting Carbon Fiber Armboard
3" Sof-Pad for radiolucent & premium armboards
5" Sof-pad for 3-1/2" table side extensions (ea.)
4" pad for pivoting carbon fiber armboard
2" Pad for 5" table side extension (ea.)
2" Pad for 10" foot extension
5" Welded Seam Pad 18" Foot Extension/Knee Rest
5" Welded Seam Pad for Pivoting Carbon Fiber Armboard
3" Sof-pad for 5" table side extension (ea.)
4" Pad for 10" foot extension
5" Pad 3000/3003 Welded Seam
3" 3PC Pad Set 6700 Series Welded Seam
4" Pad for 40" Carbon Fiber Extension
Singer Starr Leg Stacker
Pad Lateral Brace
Pad Lateral Brace Curved
Pad Right Panel
Pad Main Body
Pad Left Panel
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility