FDA UDI
In Commercial Distribution
🇺🇸 United States
Ray-Cot
DI: 20749915000883
·
Model: 60-10
·
AMERICAN SURGICAL COMPANY, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- Ray-Cot
- Primary DI
- 20749915000883
- Version / Model
- 60-10
- Company Name
- AMERICAN SURGICAL COMPANY, LLC
- Labeler DUNS
- 151054954
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2016-06-13
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 9346c3ad-f117-42fc-a8fe-93e084e9ae5e
Device Description
Ray-Cot 3/4" x 3/4"
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
- 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 |
|---|---|---|---|---|
| HBA | Neurosurgical Paddie | Neurology | 882.4700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13702 | Neurosurgical sponge | A sterile absorbent material intended to be used on the brain to remove blood and other fluids during an operation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20749915000883 | GS1 | ||||
| Unit of Use | 10749915000886 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K902921 | 000 |