FDA.reportPublic FDA data

Halyard

Primary DI
20885632373074
Brand
Halyard
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
48715
Device description
FOAM POSITIONER PRONE AND LATERAL HEAD SLOTTED POLYURETHANE FOAM BLUE DISPOSABLE NOT MADE WITH NATURAL RUBBER LATEX HALYARD
Published
2022-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

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
20885632373074PackageGS112In Commercial Distribution
10885632373077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088563237307420885632373074
1088563237307710885632373077

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding headrest, single-useA 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 single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007941230
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885632434266Halyard563482026-05-22
10885632434303Halyard563522026-05-22
10885632468490Halyard614862026-05-22
10885632468506Halyard614872026-05-22
10885632468513Halyard614882026-05-22
10885632468520Halyard614892026-05-22
10885632509032Halyard620732026-05-22
10885632509049Halyard620742026-05-22
10885632509056Halyard620752026-05-22
10885632509063Halyard620762026-05-22
10885632510199Halyard620772026-05-22
10885632521751SurgiTrackSM450130D17D2026-05-22
10885632517105SurgiTrackSM4500410F102026-03-23
10885632516429SurgiTrackSM4500309F242026-03-17
30885632495469HalyardIDSG10012026-03-13
20885632495851HalyardIDSG10022026-03-13
20885632495868HalyardIDSG10032026-03-13
20885632495875HalyardIDSG10042026-03-13
20885632495882HalyardIDSG10052026-03-13
20885632496742HalyardIDSG10062026-03-13

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