FDA.reportPublic FDA data

NA

Primary DI
00810050241458
Brand
NA
Company
DOMICO MED-DEVICE, LLC
Model
9077
Device description
PAD, ROLLED EDGE FOOT EXTENSION
Published
2020-09-24
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
00810050241458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810050241458008100502414588100502414580810050241458

GMDN Terms#

Term, Definition table
TermDefinition
Radiological general body-part positionerA device intended to facilitate adequate positioning and immobilization of a patient’s body part during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures; it is not dedicated to a specific part of the body. The device is in the form of a frame, board, cushion, or preformed pad that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081253414
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810050245579NA278092025-12-09
00810050245562NA335572025-09-24
10810050245545NA60012024-12-31
10810050245552NA60022024-12-31
00810050245524NA91252024-06-21
00810050245531NA91262024-06-21
00810050245517NA333722023-12-29
00810050245500NA4-UF2023-10-31
10810050245446NA60002023-10-13
00810050245494NA2822023-10-13
00810050245470NA169-202023-05-01
00810050245487NA2-UF2023-05-01
00810050240840NA1592020-06-11
00810050243148NA128-UF2020-08-12
00810050245289NA1632022-05-27
00810050245302NA142-202022-05-27
00810050245456NA303-UF2022-11-18
00810050245432NA209-202022-11-10
00810050245401NA333502022-10-31
00810050245425NA108-82022-10-25

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