ShroudGuard™ - ShroudGuard Surround HANA OR Table Pedestal Protector for Mizuho OSI® Hana® Orthopedic
2025-07-09
DAN ALLEN SURGICAL
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010610979 | 3010610979 | DAN ALLEN SURGICAL | 1 | N | 2026-01-01 | 11110 Kinsman Rd. Suite 50 Newbury OH US 44065 |
Registered Device Listings#
| Registration key | Listing key |
|---|---|
| 165653 | 1599134913 |
| 165653 | 1612788513 |
| 165653 | 1489670895 |
GUDID#
ShroudGuard™ - Column Shield OR Table Pedestal Protector for Stryker/Berchtold® Operon D770, D820, D830, D850, D860
2025-03-11
TrenGuard™ - TrenGuard Patient Support Frame Bariatric - For use with TrenGuard Packs and accessories.
2024-11-11
TrenGuard™ - TrenGuard Dynamic Patient Support Frame - For use with TrenGuard Packs and accessories.
2022-08-18
TrenGuard™ - TrenGuard Patient Support Frame - For use with TrenGuard Packs and accessories.
2021-05-17
TrenGuard™ - TrenGuard Patient Support Frame Wide - For use with TrenGuard Packs and accessories.
2021-05-17
ShroudGuard™ - ShroudGuard OR Table Pedestal Protector for Merivaara Promerix™ and Promerix™ B3
2024-11-11
TrenGuard™ - TrenGuard 450 Solo Wedge Packs - 12 Each disposable packs (each pack includes one wedge bolster)
2024-11-11
ShroudGuard™ - ShroudGuard OR Table Pedestal Protector for Trumpf® 7000/7000dv
2024-11-11
TrenGuard™ - TrenGuard 600 Solo Wedge Packs - 12 each disposable packs (each pack includes one wedge bolster).
2024-11-11
ShroudGuard™ - ShroudGuard Surround OD OR Table Pedestal Protector for Stryker/Berchtold® Operon D770, D820, D830, D850, D860
2024-10-24
ShroudGuard™ - ShroudGuard Surround 5085+ OR Table Pedestal Protector for STERIS® 5085, 5095
2024-06-25
ShroudGuard™ - ShroudGuard Surround 4085+ OR Table Pedestal Protector for STERIS® 4085, 4095
2024-06-25
ShroudGuard™ - ShroudGuard Surround 3085+ OR Table Pedestal Protector for STERIS® Amsco 3080, 3085
2024-06-25
TrenGuard™ - TrenGuard Hook Fastener Service Kit
2023-01-31
TrenGuard™ - "TrenGuard 450 CLASSIC Wedge Packs - Each 4-piece Pack contains: Wedge ""Speed Bump"" Bolster, Head Stabilizing Pillow, and 2 Lateral Stabilizing Pillows. Weight limit up to 204 kg. Case of 12 ea. 00811836030129 (model #55303)"
2021-05-17
TrenGuard™ - "TrenGuard 450 HYBRID Packs - Each 2-piece Pack contains: ""Speed Bump"" Bolster and Head Stabilizing Pillow. For use with Reusable Lateral Stabilizing Pillows as part of HYBRID system. Weight limit up to 204 kg. Case of 12 ea. 00811836030105 (model #55104)"
2021-05-17
TrenGuard™ - "TrenGuard 450 HYBRID Wedge Packs - Each 4-piece Pack contains: Wedge ""Speed Bump"" Bolster and Head Stabilizing Pillow. For use with Reusable Lateral Stabilizing Pillows as part of HYBRID system. Weight limit up to 204 kg. Case of 12 ea. 00811836030143 (model #55461)"
2021-05-17
TrenGuard™ - "TrenGuard 600 CLASSIC Packs - Each 4-piece Pack contains: ""Speed Bump"" Bolster, Head Stabilizing Pillow, and 2 Lateral Stabilizing Pillows. Weight limit up to 250 kg. Case of 12 ea. 00811836030174 (model #56203)"
2021-05-17
TrenGuard™ - "TrenGuard 600 HYBRID Packs - Each 2-piece Pack contains: ""Speed Bump"" Bolster and Head Stabilizing Pillow. For use with Reusable Lateral Stabilizing Pillows as part of HYBRID system. Weight limit up to 250 kg. Case of 12 ea. 00811836030198 (model #56202)"
2021-05-17
TrenGuard™ - "TrenGuard 600 CLASSIC Wedge Packs - Each 4-piece Pack contains: Wedge ""Speed Bump"" Bolster, Head Stabilizing Pillow, and 2 Lateral Stabilizing Pillows. Weight limit up to 250 kg. Case of 12 ea. 00811836030211 (model #56502)"
2021-05-17
TrenGuard™ - "TrenGuard 600 HYBRID Wedge Packs - Each 4-piece Pack contains: Wedge ""Speed Bump"" Bolster and Head Stabilizing Pillow. For use with Reusable Lateral Stabilizing Pillows as part of HYBRID system. Weight limit up to 250 kg. Case of 12 ea. 00811836030235 (model #56481)"
2021-05-17
ArmGuard™ - ArmGuard BASIC Packs - Each Pack contains 2 padded arm protectors, 20 in 51 cm long. Case of 12 ea. 00811836030396 (model #40103)
2021-05-17
ArmGuard™ - ArmGuard BASIC Packs - Each Pack contains 2 padded arm protectors, 20 in 51 cm long. Case of 12 ea. 00811836030419 (model #40401)
2021-05-17
ArmGuard™ - ArmGuard XL Width Extender Packs - Each Pack contains: Two Width Extender Pads for table mattresses up to 4 in 10.2 cm.Case of 12 ea. 00811836030457 (model #40204)
2021-05-17
TrenGuard™ - "TrenGuard 450 CLASSIC Packs - Each 4-piece Pack contains: ""Speed Bump"" Bolster, Head Stabilizing Pillow, and 2 Lateral Stabilizing Pillows. Weight limit up to 204 kg. Case of 12 ea. 00811836030082 (model #55103)"
2021-05-17
ArmGuard™ - ArmGuard Width Extender Packs - Each Pack contains: Two Width Extender Pads for table mattresses up to 3 in 7.6 cm.Case of 12 ea. 00811836030433 (model #40203)
2021-05-17
TrenGuard™ - TrenGuard Patient Positioning Kit Hillrom US - Includes TrenGuard Patient Support Frame (00811836030006) and one TrenGuard 600 CLASSIC Pack (00811836030174) in a TrenGuard CarryCase with a case of TrenGuard 450 CLASSIC Packs (20811836030086 12 each 00811836030082)
2021-08-01
TrenGuard™ - TrenGuard 450 HYBRID Reusable Lateral Stabilizing Pillow - Reusable Lateral Stabilizing Pillow for use with HYBRID system.
2021-05-17
TrenGuard™ - TrenGuard 600 HYBRID Reusable Lateral Stabilizing Pillow - Reusable Lateral Stabilizing Pillow for use with HYBRID system.
2021-05-17
ArmGuard™ - ArmGuard Rail-Mounted Sled - Secures to OR table rail with slotted rail clamp. Width-adjustable to add up to 6 in 15.2 cm. For use with ArmGuard Packs and accessories.
2021-05-17
ArmGuard™ - ArmGuard Classic Sled Kit - Includes 2 Standard Sleds (00811836030372) and 2 Bariatric Sleds (00811836030389), for use with ArmGuard Packs and accessories
2021-05-17
ArmGuard™ - ArmGuard Standard Sled - For use with ArmGuard Packs and accessories.
2021-05-17
ArmGuard™ - ArmGuard Bariatric Sled - Sled with extended base for patients wider than OR table. For use with ArmGuard Packs and Width Extender Packs.
2021-05-17
FaceGuard™ - "FaceGuard Flat Head Shield / Instrument Tray - Flat ""hold the MAYO"" tray (00811836030518) with Universal FaceGuard frame (00811836030525)."
2021-05-17
FaceGuard™ - FaceGuard Dual-Angle Head Shield / Instrument Tray - Dual-angle tray (00811836030501), designed for Trendelenburg position, and Universal FaceGuard frame (00811836030525).
2021-05-17
FaceGuard™ - "FaceGuard Combo Dual-Angle and Flat Trays - Dual-angle (00811836030501) and flat ""hold the MAYO"" (00811836030518) trays with Universal FaceGuard frame (00811836030525)."
2021-05-17
FaceGuard™ - FaceGuard Dual-Angle Tray - Dual-angle tray designed for Trendelenburg position. For use with FaceGuard Frame (00811836030525).
2021-05-17
FaceGuard™ - "FaceGuard Flat Tray - Flat ""hold the MAYO"" tray. For use with FaceGuard Frame (00811836030525)."
2021-05-17
FaceGuard™ - FaceGuard Flat Frame - FaceGuard Universal Frame, width-adjustable. For use with FaceGuard Flat Tray (00811836030518) or Dual-Angle Tray (00811836030501).
2021-05-17