FDA.reportPublic FDA data

Phoebe Main Total Joint LF *PB

Primary DI
00817395020762
Brand
Phoebe Main Total Joint LF *PB
Company
PACKROOM LLC
Model
PM330
Device description
Phoebe Main Total Joint LF *PB
Published
2018-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817395020762PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817395020762008173950207628173950207620817395020762

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, single-useA collection of surgical instruments intended to be used for cutting and forming bone to enable the implantation of a joint prosthesis. The instruments include various metallic and/or plastic disposable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks, trial prosthesis) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
015179820
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817395024425Kit, Ped Intub Gray 3-5kg NGHSKT7700AINA2026-04-27
00817395024418Pack, CABG KennestoneWK221A2026-03-18
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