FDA UDI
In Commercial Distribution
🇺🇸 United States
NEGA Vaginal Delivery *RFID PB
DI: 00817395023657
·
Model: NG185RFPBB
·
PACKROOM LLC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NEGA Vaginal Delivery *RFID PB
- Primary DI
- 00817395023657
- Version / Model
- NG185RFPBB
- Company Name
- PACKROOM LLC
- Labeler DUNS
- 015179820
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-18
- Public Version
- 1
- Public Version Date
- 2024-03-26
- Public Version Status
- New
- Public Device Record Key
- c14882d3-fc5a-42d5-a693-6f7e2e42bc5e
Device Description
NEGA Vaginal Delivery *RFID PB Huntsville Vag Perineal
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60644 | Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use | A collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817395023657 | GS1 |