FDA UDI
In Commercial Distribution
🇺🇸 United States
Protexer
DI: 00688162400007
·
Model: ICP-CPPSB 24"
·
ICP MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Protexer
- Primary DI
- 00688162400007
- Version / Model
- ICP-CPPSB 24"
- Catalog Number
- ICP-CPPSB0024
- Company Name
- ICP MEDICAL, LLC
- Labeler DUNS
- 078780963
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-31
- Public Version
- 1
- Public Version Date
- 2022-11-08
- Public Version Status
- New
- Public Device Record Key
- 07706cff-d210-42cf-9a60-114ca340fe6a
Device Description
Bouffant Cap, Blue, 24"
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
- No
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 |
|---|---|---|---|---|
| 61938 | Surgical/examination garment kit | A collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10688162400004 | GS1 | Bag | 100 | In Commercial Distribution | |
| Primary | 00688162400007 | GS1 | ||||
| Package | 20688162400001 | GS1 | Case | 10 | In Commercial Distribution |