Floyd Aorta Pack

Primary DI
00817395020175
Brand
Floyd Aorta Pack
Company
PACKROOM LLC
Model
FM110
Device description
Floyd Aorta Pack
Published
2018-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817395020175PrimaryGS10

GMDN Terms

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

Regulatory Flags

DUNS number
015179820
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00817395024401NEGA Lithotomy RFID PackNG115RFA2026-02-20
00817395024364Pack, Angio HamiltonHM105A2025-09-03
00817395024357Kennestone Upper Extremity PackWK420B2025-09-02
00817395024203Pack, Basic NEGA *RFIDNG235RFD2025-04-09
00817395024067Kit, Kennestone PermacathKT410.0012024-06-25
00817395024074Kit, Sub Extremity NEGAKT420.0022024-06-25
00817395024081Kit, Ped Intub Blue 19-23kg NGHSKT7700BIN.0072024-06-25
00817395024098Kit, Ped Nurse Blue 19-23kg NGHSKT7700BIV.0032024-06-25
00817395024104Kit, Ped Intub Green 30-36kg NGHSKT7700GIN.0052024-06-25
00817395024111Kit, Ped Nurse Green 30-36kg NGHSKT7700GIV.0022024-06-25
00817395024128Kit, Ped Intub Orange 24-29kg NGHSKT7700OIN.0042024-06-25
00817395024135Kit, Ped Nurse Orange 24-29kg NGHSKT7700OIV.0012024-06-25
00817395024142Kit, Ped Intub Purple 10-11kg NGHSKT7700PIN.0052024-06-25
00817395024159Kit, Ped Nurse Purple 10-11kg NGHSKT7700PIV.0012024-06-25
00817395024166Kit, Ped Intub Pink/Red 6-9kg NGHSKT7700RIN.0072024-06-25
00817395024173Kit, Ped Nurse White 15-18kg NGHSKT7700WIV.0022024-06-25
00817395024180Kit, Ped Intub Yellow 12-14kg NGHSKT7700YIN.0052024-06-25
00817395024197Kit, Ped Nurse Yellow 12-14kg NGHSKT7700YIV.0022024-06-25
00817395023961KIT, FLOYD CATH + BIODOMEKT1402024-06-24
00817395023978Kit, Mother Care WellstarKT150B2024-06-24