FDA.reportPublic FDA data

AADCO

Primary DI
00840348506723
Brand
AADCO
Company
AADCO MEDICAL, INC.
Model
PB-122
Catalog number
PB-122
Device description
HEAD & NECK SUPPORT
Published
2022-12-07
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
false

Product Codes#

Code, Name table
CodeName
LWGSurgical Table Cushion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWGSurgical Table CushionGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840348506723PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840348506723008403485067238403485067230840348506723

GMDN Terms#

Term, Definition table
TermDefinition
Head/neck procedure positionerA noninvasive device consisting of fixed or adjustable elements (e.g., frame, board, multi-jointed structure) designed to ensure adequate support, positioning and immobilization of the patient's head, neck, and cervical spine during intraoperative procedures (e.g., cervical spine or brain surgery) or diagnostic imaging (e.g., dental x-ray procedures). It is typically mounted on an operating/examination table and allows adjustment of the height and angle of the head. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
153603204
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
00840348507690AADCOPB-505PB-5052022-12-14
00840348526493AADCON-640N-6402022-12-16
00840348526509AADCON-640DN-640D2022-12-16
00840348506396AADCOP-610P-6102022-12-14
00840348506402AADCOP-610CSP-610CS2022-12-14
00840348506419AADCOP-611P-6112022-12-14
00840348506426AADCOP-611CSP-611CS2022-12-14
00840348507997AADCOPBS-025PBS-0252022-12-14
00840348529333ErgoLiteLP-EX708LP-EX7082025-02-05
00840348529326AADCOOSP-755OSP-7552025-01-22
00840348529319AADCOPS-311APS-311A2024-11-13
00840348529302AADCOPS-405SPS-405S2024-10-21
00840348529296AADCOOSP-260NFOSP-260NF2024-10-15
00840348529289ComfortLiteLP-CL800XALP-CL800XA2024-09-09
00840348526233AADCON-101N-1012022-12-15
00840348525694AADCODB-1922CF100DB-1922CF1002022-12-19
00840348525700AADCODB-1922CF1KDB-1922CF1K2022-12-19
00840348525762AADCODB-2620NDB-2620N2022-12-19
00840348525779AADCODB-2820NDB-2820N2022-12-19
00840348526806MRI-SafeNF-500NF-5002022-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850055249431Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249448Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249455Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249462Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249479Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249486Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249493Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249509Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249516Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249011Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249028Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249035Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249042Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249059Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249103Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249233Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249240Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249257Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249264Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249271Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249288Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249295Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249301Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249349Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249356Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249363Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249370Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249387Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249394Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249400Prime Medical LLCPrime Medical LLCLWG2026-03-05