DAN ALLEN SURGICAL

FDA Registration(s)#

Registration, FEI, Name table
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 table
Registration key	Listing key
165653	1599134913
165653	1612788513
165653	1489670895

GUDID#

TrenGuard™ - TrenGuard TrueFit 600 CLASSIC Wedge Packs - Each 4-piece Pack contains: TrueFit Wedge "Speed Bump" Bolster, Head Stabilizing Pillow, and 2 TrueFit Lateral Stabilizing Pillows. Weight limit up to 250 kg. Case of 12 ea. 00811836030938 (model #56803)
Dan Allen Surgical LLC
2026-06-26
TrenGuard™ - TrenGuard TrueFit 450 CLASSIC Packs - Each 4-piece Pack contains: TrueFit "Speed Bump" Bolster, Head Stabilizing Pillow, and 2 TrueFit Lateral Stabilizing Pillows. Weight limit up to 204 kg. Case of 12 ea. 00811836030914 (model #57451)
Dan Allen Surgical LLC
2026-06-26
TrenGuard™ - TrenGuard TrueFit Dynamic Patient Support Frame - For use with TrenGuard TrueFit Packs and accessories.
Dan Allen Surgical LLC
2026-06-26
ShroudGuard™ - ShroudGuard Surround HANA OR Table Pedestal Protector for Mizuho OSI® Hana® Orthopedic
Dan Allen Surgical LLC
2025-07-09
ShroudGuard™ - Column Shield OR Table Pedestal Protector for Stryker/Berchtold® Operon D770, D820, D830, D850, D860
Dan Allen Surgical LLC
2025-03-11
TrenGuard™ - TrenGuard Patient Support Frame Wide - For use with TrenGuard Packs and accessories.
Dan Allen Surgical LLC
2021-05-17
TrenGuard™ - TrenGuard Patient Support Frame - For use with TrenGuard Packs and accessories.
Dan Allen Surgical LLC
2021-05-17
TrenGuard™ - TrenGuard Dynamic Patient Support Frame - For use with TrenGuard Packs and accessories.
Dan Allen Surgical LLC
2022-08-18
TrenGuard™ - TrenGuard Patient Support Frame Bariatric - For use with TrenGuard Packs and accessories.
Dan Allen Surgical LLC
2024-11-11
TrenGuard™ - TrenGuard 600 Solo Wedge Packs - 12 each disposable packs (each pack includes one wedge bolster).
Dan Allen Surgical LLC
2024-11-11
ShroudGuard™ - ShroudGuard OR Table Pedestal Protector for Trumpf® 7000/7000dv
Dan Allen Surgical LLC
2024-11-11
TrenGuard™ - TrenGuard 450 Solo Wedge Packs - 12 Each disposable packs (each pack includes one wedge bolster)
Dan Allen Surgical LLC
2024-11-11
ShroudGuard™ - ShroudGuard OR Table Pedestal Protector for Merivaara Promerix™ and Promerix™ B3
Dan Allen Surgical LLC
2024-11-11
ShroudGuard™ - ShroudGuard Surround OD OR Table Pedestal Protector for Stryker/Berchtold® Operon D770, D820, D830, D850, D860
Dan Allen Surgical LLC
2024-10-24
ShroudGuard™ - ShroudGuard Surround 3085+ OR Table Pedestal Protector for STERIS® Amsco 3080, 3085
Dan Allen Surgical LLC
2024-06-25
ShroudGuard™ - ShroudGuard Surround 4085+ OR Table Pedestal Protector for STERIS® 4085, 4095
Dan Allen Surgical LLC
2024-06-25
ShroudGuard™ - ShroudGuard Surround 5085+ OR Table Pedestal Protector for STERIS® 5085, 5095
Dan Allen Surgical LLC
2024-06-25
TrenGuard™ - TrenGuard Hook Fastener Service Kit
Dan Allen Surgical LLC
2023-01-31
FaceGuard™ - FaceGuard Flat Frame - FaceGuard Universal Frame, width-adjustable. For use with FaceGuard Flat Tray (00811836030518) or Dual-Angle Tray (00811836030501).
Dan Allen Surgical LLC
2021-05-17
FaceGuard™ - "FaceGuard Flat Tray - Flat ""hold the MAYO"" tray. For use with FaceGuard Frame (00811836030525)."
Dan Allen Surgical LLC
2021-05-17
FaceGuard™ - FaceGuard Dual-Angle Tray - Dual-angle tray designed for Trendelenburg position. For use with FaceGuard Frame (00811836030525).
Dan Allen Surgical LLC
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)."
Dan Allen Surgical LLC
2021-05-17
FaceGuard™ - FaceGuard Dual-Angle Head Shield / Instrument Tray - Dual-angle tray (00811836030501), designed for Trendelenburg position, and Universal FaceGuard frame (00811836030525).
Dan Allen Surgical LLC
2021-05-17
FaceGuard™ - "FaceGuard Flat Head Shield / Instrument Tray - Flat ""hold the MAYO"" tray (00811836030518) with Universal FaceGuard frame (00811836030525)."
Dan Allen Surgical LLC
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.
Dan Allen Surgical LLC
2021-05-17
ArmGuard™ - ArmGuard Standard Sled - For use with ArmGuard Packs and accessories.
Dan Allen Surgical LLC
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
Dan Allen Surgical LLC
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.
Dan Allen Surgical LLC
2021-05-17
TrenGuard™ - TrenGuard 600 HYBRID Reusable Lateral Stabilizing Pillow - Reusable Lateral Stabilizing Pillow for use with HYBRID system.
Dan Allen Surgical LLC
2021-05-17
TrenGuard™ - TrenGuard 450 HYBRID Reusable Lateral Stabilizing Pillow - Reusable Lateral Stabilizing Pillow for use with HYBRID system.
Dan Allen Surgical LLC
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)
Dan Allen Surgical LLC
2021-08-01
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)
Dan Allen Surgical LLC
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)"
Dan Allen Surgical LLC
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)
Dan Allen Surgical LLC
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)
Dan Allen Surgical LLC
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)
Dan Allen Surgical LLC
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)"
Dan Allen Surgical LLC
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)"
Dan Allen Surgical LLC
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)"
Dan Allen Surgical LLC
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)"
Dan Allen Surgical LLC
2021-05-17

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