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) (8)

Premarket Exempt

Yes

Clear

TrenGuard™ - 10811836030195 Catalog Number :

Device Description : TrenGuard 600 HYBRID Packs - Each 2-piece Pack contains: "Speed Bump" Bolster a 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)

Device Class : 1

Duns Number: 040876183

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 12

TrenGuard™ - 10811836030218 Catalog Number :

Device Description : TrenGuard 600 CLASSIC Wedge Packs - Each 4-piece Pack contains: Wedge "Speed Bum 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)

Device Class : 1

Duns Number: 040876183

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 12

TrenGuard™ - 10811836030232 Catalog Number :

Device Description : TrenGuard 600 HYBRID Wedge Packs - Each 4-piece Pack contains: Wedge "Speed Bump 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)

Device Class : 1

Duns Number: 040876183

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 12

ArmGuard™ - 10811836030393 Catalog Number :

Device Description : ArmGuard BASIC Packs - Each Pack contains 2 padded arm protectors, 20 in 51 cm ArmGuard BASIC Packs - Each Pack contains 2 padded arm protectors, 20 in 51 cm long. Case of 12 ea. 00811836030396 (model #40103)

Device Class : 1

Duns Number: 040876183

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 12

ArmGuard™ - 10811836030416 Catalog Number :

Device Class : 1

Duns Number: 040876183

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 12

ArmGuard™ - 10811836030454 Catalog Number :

Device Description : ArmGuard XL Width Extender Packs - Each Pack contains: Two Width Extender Pads f 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)

Device Class : 1

Duns Number: 040876183

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 12

TrenGuard™ - 20811836030086 Catalog Number :

Device Description : TrenGuard 450 CLASSIC Packs - Each 4-piece Pack contains: "Speed Bump" Bolster, 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)

Device Class : 1

Duns Number: 040876183

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 12

ArmGuard™ - 20811836030437 Catalog Number :

Device Description : ArmGuard Width Extender Packs - Each Pack contains: Two Width Extender Pads for 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)

Device Class : 1

Duns Number: 040876183

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 12

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