FDA UDI
In Commercial Distribution
🇺🇸 United States
Forsure
DI: 00897633001661
·
Model: 16300030
·
FORSURE MEDICAL PRODUCTS LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Forsure
- Primary DI
- 00897633001661
- Version / Model
- 16300030
- Catalog Number
- 16300030
- Company Name
- FORSURE MEDICAL PRODUCTS LLC
- Labeler DUNS
- 033809722
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-12
- Public Version
- 3
- Public Version Date
- 2021-12-22
- Public Version Status
- Update
- Public Device Record Key
- 33492c03-59b2-40b0-bde1-128351ed50a5
Device Description
A non-sterile 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 is usually made of reinforced paper or non-woven materials. This is a single-use device.
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|---|---|
| Primary | 00897633001661 | GS1 | ||||
| Package | 20897633001665 | GS1 | MASTER CASE | 5 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | BLUE W BACK TIE |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- STORE IN DRY CONDITIONS