FDA UDI
In Commercial Distribution
🇺🇸 United States
Rospital Productos Medicos
DI: 00812460028087
·
Model: SG1
·
ATLAS MEDICAL PRODUCTS LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Rospital Productos Medicos
- Primary DI
- 00812460028087
- Version / Model
- SG1
- Catalog Number
- SG1
- Company Name
- ATLAS MEDICAL PRODUCTS LLC
- Labeler DUNS
- 013112308
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-29
- Public Version
- 2
- Public Version Date
- 2021-12-22
- Public Version Status
- Update
- Public Device Record Key
- 98b88294-d756-4603-89b2-e068a3cc7134
Device Description
SURGEONS CAP: NON-WOVEN WITH TIE, BLUE, EA.
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| FYF | Cap, Surgical | General, Plastic Surgery | 878.4040 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32297 | Surgical cap, single-use | A head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material; it may also be used as a hygienic head covering in other healthcare settings. It is usually made of reinforced paper or non-woven materials. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10812460028084 | GS1 | INNER CASE | 100 | In Commercial Distribution | |
| Primary | 00812460028087 | GS1 | ||||
| Package | 20812460028081 | GS1 | CASE | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 7864739436
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | SURGEONS CAP: NON-WOVEN WITH TIE, BLUE , EA. |