FDA UDI
In Commercial Distribution
🇺🇸 United States
Spetzler - OMT
DI: M731100010
·
Model: Neuro Patties
·
OMT, LLC
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
5
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Basic Information
- Brand Name
- Spetzler - OMT
- Primary DI
- M731100010
- Version / Model
- Neuro Patties
- Catalog Number
- ALL
- Company Name
- OMT, LLC
- Labeler DUNS
- 196899772
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2017-02-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 591f42ac-7679-4bd2-bda2-e80d85839d63
Device Description
Neuro Pattie; Sterile; X-Ray detectable; Tissue Compatible Rayon; For Single Use.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| HBA | Neurosurgical Paddie | Neurology | 882.4700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32572 | Cottonoid pad | A cushion-like mass made of cotton or man-made fibres used during surgery (e.g., neurosurgery) to protect tissue, absorb fluids, and/or stop bleeding. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M7311100169 | HIBCC | Box | 5 | In Commercial Distribution | |
| Primary | M731100010 | HIBCC | ||||
| Package | M7311100159 | HIBCC | Box | 10 | In Commercial Distribution | |
| Unit of Use | K900005 | HIBCC | ||||
| Package | M7311100189 | HIBCC | Box | 3 | In Commercial Distribution |
Customer Contacts
- Phone
- 954-327-5687
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K020736 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 60 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 30 – 70 Degrees Fahrenheit