FDA.reportPublic FDA data

Aero-Med

Primary DI
50810010892237
Brand
Aero-Med
Company
Aero-Med, Ltd.
Model
00WOUNDKIT01
Catalog number
00WOUNDKIT01
Device description
Dry-Bridge Kit
Published
2019-06-27
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
true

Product Codes#

Code, Name table
CodeName
LRPTRAY, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50810010892237PackageGS150In Commercial Distribution
00810010892232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5081001089223750810010892237
00810010892232008100108922328100108922320810010892232

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
194550042
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
50192253068748Aero-MedCA38075BCA38075B2025-05-01
50885380208308Aero-MedCA1500ACA1500A2025-04-18
50885380183667Aero-MedCA18750ACA18750A2025-04-15
50885380207721Aero-MedCA18725BCA18725B2025-04-15
50810010894729Aero-MedQUE3325QUE33252025-04-10
50885380207707Aero-MedCA38075BCA38075B2025-04-08
50885380207714Aero-MedCA38100BCA38100B2025-04-08
50885380208063Aero-MedCA14800BCA14800B2025-04-07
50885380198715Aero-MedCA54550CA545502024-01-08
50885380207745Aero-MedCA61875CA618752025-04-02
50885380198708Aero-MedCA32250BCA32250B2024-01-08
50885380207455Aero-MedCA61175CA611752025-03-20
50885380207677Aero-MedCA61900CA619002025-03-19
50810010894774Aero-MedAMM19300AMM193002025-03-06
50885380207363Aero-MedCA59025CA590252025-03-03
50885380207448Aero-MedCA59000CA590002025-03-03
50810010894736Aero-MedAMM18850AMM188502025-02-11
50810010894743Aero-MedAMM18875AMM188752025-02-11
50885380205536Aero-MedCA60225CA602252024-10-07
50885380206823Aero-MedCA60675CA606752025-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956258730CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956350205CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956378162CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956402843CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956460690CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956461840CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956470613CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956482159CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956488533CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956491236CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956492592CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956492998CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956494824CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
04046826447953Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-03-24
04046826495923Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-03-24
04046826495978Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-03-24
50198956435382CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-24
50198956248968CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956284027CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956293043CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956304954CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956305630CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956308433CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956313703CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956322590CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956325607CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956331677CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956332292CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956348255CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956356526CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23