FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NEURAY ®
DI: 00643169932012
·
Model: 8004003
·
MEDTRONIC XOMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- NEURAY ®
- Primary DI
- 00643169932012
- Version / Model
- 8004003
- Company Name
- MEDTRONIC XOMED, INC.
- Labeler DUNS
- 835465063
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-16
- Public Version
- 4
- Public Version Date
- 2023-08-30
- Public Version Status
- Update
- Public Device Record Key
- 2dea3e74-cc3e-4432-b9e2-384a1000e3f3
- Distribution End Date
- 2021-07-29
Device Description
PACKING 8004003 NEURAY 200PK 25X25MM
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HBA | NEUROSURGICAL PADDIE | Neurology | 882.4700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38496 | Radiopaque woven surgical sponge | A non-medicated device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20643169932016 | GS1 | PK | 200 | Not in Commercial Distribution | 2021-07-29 |
| Primary | 00643169932012 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K923027 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 25.0 | Millimeter | |
| Width | 25.0 | Millimeter |