FDA UDI
In Commercial Distribution
🇺🇸 United States
HSG / SIS Universal Procedure Tray
DI: 00850024383005
·
Model: NHSC5057
·
National Healthcare Supply Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HSG / SIS Universal Procedure Tray
- Primary DI
- 00850024383005
- Version / Model
- NHSC5057
- Catalog Number
- 5057
- Company Name
- National Healthcare Supply Corporation
- Labeler DUNS
- 104243644
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-05
- Public Version
- 1
- Public Version Date
- 2021-05-13
- Public Version Status
- New
- Public Device Record Key
- d9460fed-026c-4274-8752-48343c1b0b7b
Device Description
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
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LRO | General Surgery Tray | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44060 | Obstetrical/gynaecological surgical procedure kit, medicated | A collection of various sterile surgical instruments, dressings, pharmaceuticals, and materials intended to be used during obstetrical/gynaecological surgery; it is a general-purpose obstetrical/gynaecological surgical kit, and as such is not dedicated to a specific procedure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850024383005 | GS1 | ||||
| Package | 10850024383002 | GS1 | CS | 10 | In Commercial Distribution |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid excessive heat and shield from direct light.