Duns Number:104243644
Device Description: HSG / SIS Universal Procedure Tray w 1.0 CSR WRAP,1.00 DRAPE SHEET 40X48,1.00 FENESTRATED HSG / SIS Universal Procedure Tray w 1.0 CSR WRAP,1.00 DRAPE SHEET 40X48,1.00 FENESTRATED DRAPE,1.00 FORCEP,4.00 GAUZE 4X4,2.00 LUBE JELLY,1.00 NEEDLE 18G,1.00 OB PAD,1.00 OS FINDER,1.00 PRESSURE TUBING,1.00 PVP OINTMENT,2.00 PVP SOLUTION,3.00 RAYON TIP SWAB,1.00 SOUND UTERINE,2.00 SPONGE STICK,1.00 STOPCOCK 1 WAY MALE L/L SWIVEL,1.00 SYRINGE 20ML,1.00 TRAY,1.00 TRAY,1.00 TRAY RECTANGLE 11X9.5X2,1.00 VAGINAL SPECULUM
Catalog Number
5057
Brand Name
HSG / SIS Universal Procedure Tray
Version/Model Number
NHSC5057
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRO
Product Code Name
General Surgery Tray
Public Device Record Key
d9460fed-026c-4274-8752-48343c1b0b7b
Public Version Date
May 13, 2021
Public Version Number
1
DI Record Publish Date
May 05, 2021
Package DI Number
10850024383002
Quantity per Package
10
Contains DI Package
00850024383005
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS