Dan Allen Surgical LLC

Address:12373 Kinsman Road,Newbury,OH,44065,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Support, Patient Position (CCX) (6) Table And Attachments, Operating-Room (BWN) (4)

Premarket Exempt

Yes

Clear

FaceGuard™ - 00811836030495 Catalog Number :

Device Description : FaceGuard Combo Dual-Angle and Flat Trays - Dual-angle (00811836030501) and flat FaceGuard Combo Dual-Angle and Flat Trays - Dual-angle (00811836030501) and flat "hold the MAYO" (00811836030518) trays with Universal FaceGuard frame (00811836030525).

Device Class : 1

Duns Number: 040876183

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : No

Device Count : 1

FaceGuard™ - 00811836030501 Catalog Number :

Device Description : FaceGuard Dual-Angle Tray - Dual-angle tray designed for Trendelenburg position. FaceGuard Dual-Angle Tray - Dual-angle tray designed for Trendelenburg position. For use with FaceGuard Frame (00811836030525).

Device Class : 1

Duns Number: 040876183

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : No

Device Count : 1

FaceGuard™ - 00811836030518 Catalog Number :

Device Description : FaceGuard Flat Tray - Flat "hold the MAYO" tray. For use with FaceGuard Frame (0 FaceGuard Flat Tray - Flat "hold the MAYO" tray. For use with FaceGuard Frame (00811836030525).

Device Class : 1

Duns Number: 040876183

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : No

Device Count : 1

FaceGuard™ - 00811836030525 Catalog Number :

Device Description : FaceGuard Flat Frame - FaceGuard Universal Frame, width-adjustable. For use with FaceGuard Flat Frame - FaceGuard Universal Frame, width-adjustable. For use with FaceGuard Flat Tray (00811836030518) or Dual-Angle Tray (00811836030501).

Device Class : 1

Duns Number: 040876183

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : No

Device Count : 1

TrenGuard™ - 00811836030785 Catalog Number :

Device Description : TrenGuard Patient Positioning Kit Hillrom US - Includes TrenGuard Patient Suppor 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)

Device Class : 1

Duns Number: 040876183

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

TrenGuard™ - 00811836030815 Catalog Number :

Device Description : TrenGuard Patient Support Frame Wide - For use with TrenGuard Packs and accessories.

Device Class : 1

Duns Number: 040876183

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

TrenGuard™ - 10811836030089 Catalog Number :

Device Description : TrenGuard 450 CLASSIC Wedge Packs - Each 4-piece Pack contains: Wedge "Speed Bum 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)

Device Class : 1

Duns Number: 040876183

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 12

TrenGuard™ - 10811836030102 Catalog Number :

Device Description : TrenGuard 450 HYBRID Packs - Each 2-piece Pack contains: "Speed Bump" Bolster an 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)

Device Class : 1

Duns Number: 040876183

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 12

TrenGuard™ - 10811836030140 Catalog Number :

Device Description : TrenGuard 450 HYBRID Wedge Packs - Each 4-piece Pack contains: Wedge "Speed Bump 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)

Device Class : 1

Duns Number: 040876183

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 12

TrenGuard™ - 10811836030171 Catalog Number :

Device Description : TrenGuard 600 CLASSIC Packs - Each 4-piece Pack contains: "Speed Bump" Bolster, 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)

Device Class : 1

Duns Number: 040876183

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 12

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