FDA.reportPublic FDA data

Phoebe Main Shoulder Scope Pk LF

Primary DI
00817395020724
Brand
Phoebe Main Shoulder Scope Pk LF
Company
PACKROOM LLC
Model
PM300
Device description
Phoebe Main Shoulder Scope Pk LF
Published
2018-09-24
Public version status
Update
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
00817395020724PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817395020724008173950207248173950207240817395020724

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
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