FDA UDI
In Commercial Distribution
🇺🇸 United States
Instrument pouch
DI: 05051223004264
·
Model: PS4050
·
PURPLE SURGICAL INTERNATIONAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Instrument pouch
- Primary DI
- 05051223004264
- Version / Model
- PS4050
- Catalog Number
- PS4050
- Company Name
- PURPLE SURGICAL INTERNATIONAL LIMITED
- Labeler DUNS
- 239403863
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-17
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- dc7e80c2-c3bc-4302-a893-684f0231b543
Device Description
The Instrument Pouch is used for securing instruments in a convenient housing close to the surgical site, minimising hand to hand transfer.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | 884.1720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58967 | Instrument management bag, sterile | A sterile flexible plastic container intended to hold/collect instruments, cables, or other equipment during a surgical procedure or other clinical intervention, typically being attached to a drape or other support close to or inside the sterile field of operation/intervention. It may have a variety of designs, e.g., number of pouches, adhesive/non-adhesive, overall shape and size. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 55051223004269 | GS1 | shipping carton | 100 | In Commercial Distribution | |
| Package | 35051223004265 | GS1 | inner | 25 | In Commercial Distribution | |
| Primary | 05051223004264 | GS1 |
Customer Contacts
- Phone
- +441923839333
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 95mm width x 405 mm depth |