FDA UDI
In Commercial Distribution
🇺🇸 United States
ESP™
DI: 08714729735199
·
Model: M001201140
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ESP™
- Primary DI
- 08714729735199
- Version / Model
- M001201140
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2019-02-21
- Public Version Status
- Update
- Public Device Record Key
- c72daf88-13cf-4c9c-988a-996680c38032
Device Description
Radiation Reduction Examination Gloves
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- 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 |
|---|---|---|---|---|
| IWP | Radiographic protective Glove | Radiology | 892.6500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59061 | Radiation attenuating Hevea-latex surgical/procedural glove | A sterile device made of Hevea natural rubber latex (NRL) 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 wearer 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 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 | 08714729175643 | GS1 | 3 | In Commercial Distribution | ||
| Primary | 08714729735199 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 9 NA Effective Length |