FDA.reportPublic FDA data

ALLEN

Primary DI
00615521031916
Brand
ALLEN
Company
ALLEN MEDICAL SYSTEMS, INC.
Model
103004
Catalog number
216054
Device description
HEAD POSITIONER ICU PRONE
Published
2023-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCXSUPPORT, PATIENT POSITION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00615521031916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00615521031916006155210319166155210319160615521031916

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical headrestA device designed to be attached to an appropriate operating table to support and immobilize the head of a recumbent patient during a neurosurgical procedure. The headrest is typically made of metal and synthetic materials that incorporate a semicircular cupped cushion or pad that provides a softer surface for the patient's head to rest in. It is available in various shapes and sizes and will typically include mechanical mechanisms that enable adjustment to facilitate surgeon access to the skull. This device may be attached to dedicated chairs used for neurosurgical procedures. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(315)685-2834GDSN_SUPPORT@MYHILLROM.ONMICROSOFT.COM
+1(800)445-3730us.customerservice@hill-rom.com

Regulatory Flags#

DUNS number
147805894
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00615521004354ArthrexAR-1627-052024-05-23
00615521004385ArthrexAR-1627-102024-05-23
00615521004392ArthrexAR-1627-112024-05-23
00615521004408ArthrexAR-1627-11EU2024-05-23
00615521004415ArthrexAR-1627-11UK2024-05-23
00615521004422ArthrexAR-1627-122024-05-23
00615521004439ArthrexAR-1627-12EU2024-05-23
00615521004460ArthrexAR-1627-152024-05-23
00615521004491ArthrexAR-1627-172024-05-23
00615521004507ArthrexAR-1627-182024-05-23
00615521004514ArthrexAR-1627-202024-05-23
00615521004521ArthrexAR-1650-012024-05-23
00615521004552ArthrexAR-1650-042024-05-23
00615521004569ArthrexAR-1650-052024-05-23
00615521004583ArthrexAR-1650-072024-05-23
00615521004590ArthrexAR-1650-082024-05-23
00615521004606ArthrexAR-1650-092024-05-23
00615521004613ArthrexAR-1650-102024-05-23
00615521004620ArthrexAR-1650-112024-05-23
00615521004668ArthrexAR-1713-012024-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060624123696CS Align Pro Support - Replacement PadsCARE SURGICAL LIMITEDCCX2026-03-23
05060624126970CS Align Pro SupportCARE SURGICAL LIMITEDCCX2026-03-23
00850055249066Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249134Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249141Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249165Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249172Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249189Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249196Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249202Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249219Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249318Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249325Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249332Prime Medical LLCPrime Medical LLCCCX2026-03-05
05060624127182CS Easy Prone (170 mm) - GreyCARE SURGICAL LIMITEDCCX2026-01-26
05060624127199CS Easy Prone (170 mm) - Chest only (Grey)CARE SURGICAL LIMITEDCCX2026-01-26
05060624127342CS FlexiFin™ Stirrup Pads (Pair) – Low BMI Patients CARE SURGICAL LIMITEDCCX2026-01-26
05060624127366CS Easy Prone (150 mm) - GreyCARE SURGICAL LIMITEDCCX2026-01-26
05060624127373CS Easy Prone (150 mm) - Chest only (Grey)CARE SURGICAL LIMITEDCCX2026-01-26
05060624127397CS Easy Prone (150 mm) - Pelvis Only (Grey) CARE SURGICAL LIMITEDCCX2026-01-26
05060624127403CS Easy Prone (170 mm) - Pelvis only (Grey)CARE SURGICAL LIMITEDCCX2026-01-26
05060624127458CS Easy Prone (200 mm) - GreyCARE SURGICAL LIMITEDCCX2026-01-26
05060624127465CS Easy Prone (200 mm) - Chest only (Grey)CARE SURGICAL LIMITEDCCX2026-01-26
05060624127472CS Easy Prone (200 mm) - Pelvis only (Grey)CARE SURGICAL LIMITEDCCX2026-01-26
00199972000184CuraplexBOUND TREE MEDICAL, LLCCCX2026-01-23
00199972000191CuraplexBOUND TREE MEDICAL, LLCCCX2026-01-23
00199972000207CuraplexBOUND TREE MEDICAL, LLCCCX2026-01-23
00199972000214CuraplexBOUND TREE MEDICAL, LLCCCX2026-01-23
50749756401352DeRoyalDEROYAL INDUSTRIES, INC.CCX2026-01-22
50749756401376DeRoyalDEROYAL INDUSTRIES, INC.CCX2026-01-22