FDA UDI
In Commercial Distribution
🇺🇸 United States
Freeguard
DI: 08054301890664
·
Model: Model190
·
EMERSON & CO SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Freeguard
- Primary DI
- 08054301890664
- Version / Model
- Model190
- Catalog Number
- Model190
- Company Name
- EMERSON & CO SRL
- Labeler DUNS
- 630558211
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-16
- Public Version
- 2
- Public Version Date
- 2019-02-21
- Public Version Status
- Update
- Public Device Record Key
- a355d367-e4fc-468b-ae47-0ca08076de75
Device Description
Radiation Attenuating Surgical Glove
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
- Yes
- 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 |
|---|---|---|---|---|
| KGO | Surgeon'S Gloves | General, Plastic Surgery | 878.4460 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59062 | Radiation attenuating polyisoprene surgical/procedural glove | A sterile device made of polyisoprene intended as a protective barrier when worn on the hands of healthcare providers at the surgical/procedural site; its inner surface is not powdered and the glove's material matrix contains radiation attenuating material intended to limit exposure to incident radiation (e.g., during fluoroscopy). It is used mainly as a two-way barrier to protect patient and staff from contaminants. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, elasticity) and uniformity of dimensions (i.e., sizing consistency). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08054301891401 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 08054301890664 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- dry place away from light and heat sources