FDA.report

Face-Cradle

Primary DI
30641043520004
Brand
Face-Cradle
Company
MERCURY ENTERPRISES, INC.
Model
10-52000
Published
2020-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
CCXSupport, Patient Position

Product Code Classifications

CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30641043520004PackageGS11In Commercial Distribution
10641043520000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3064104352000430641043520004
1064104352000010641043520000

GMDN Terms

TermDefinition
Freestanding headrest, reusableA device designed to be placed on a flat surface (e.g., operating/examination table, stretcher) to support and stabilize the head of a recumbent patient, typically in preparation for and during many types of medical procedures or examinations; it is not attached to a parent device. The headrest is typically made of shock-absorbing materials (e.g., memory foam, gel) that cushion the head and is available in various sizes and shapes including head pad, head ring, and concave ergonomic holders with fingered lateral supports to position the head. This is a reusable device after appropriate cleaning.

Sterilization Methods

Method

Contacts

PhoneEmail
727-573-0088hospitalcustomerservice@mercurymed.com

Regulatory Flags

DUNS number
032705659
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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30641043566033CPR-2 Bag10-566032025-07-15
30641043913165Neo-Tee T-Piece Resuscitator Circuit10-913162024-02-08
30641043913356Neo-Tee T-Piece Resuscitator Circuit10-913352024-02-08
30641043913653Neo-Tee T-Piece Resuscitator Circuit10-913652024-02-08
30641043564596CPR-2 Bag10-564592023-07-20
10641043885017Hand Pump Assembly88-GCT5012023-06-15
30641043564343CPR-2 Bag10-564342023-04-04
30641043566026CPR-2 Bag10-566022023-03-09
30641043564572CPR-2 Bag10-564572022-08-02
30641043553415Double Swivel Elbow Connector10-553412018-08-30
30641043553422Double Swivel Elbow Connector10-553422018-08-30
30641043553606Omni-Link/Flex-Link10-553602018-08-31
30641043553613Omni-Link/Flex-Link10-553612018-08-31
30641043553620Omni-Link/Flex-Link10-553622018-08-31
30641043553637Omni-Link/Flex-Link10-553632018-08-31
30641043320024EZflow10-320022016-03-09
30641043320055EZflow10-320052016-03-09
30641043320062EZflow10-320062016-03-09

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05060624127366CS Easy Prone (150 mm) - GreyCARE SURGICAL LIMITEDCCX2026-01-26
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