FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Pillcam
DI: 07290101363231
·
Model: FGS-0279
·
Given Imaging, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pillcam
- Primary DI
- 07290101363231
- Version / Model
- FGS-0279
- Company Name
- Given Imaging, Inc.
- Labeler DUNS
- 090073722
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2021-07-02
- Public Version Status
- Update
- Public Device Record Key
- 106cee35-eebf-4f52-9bea-1ed3eca5d118
- Distribution End Date
- 2021-03-31
Device Description
recorder accessories DR2 sm
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| NEZ | SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE | Gastroenterology, Urology | 876.1300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41134 | Video capsule endoscopy system antenna | An electrically-powered, noninvasive component of a video capsule endoscopy system designed to be attached to/worn by a patient to receive the image data signals from an ingested video capsule and transmit them to the system monitor. It typically has the form of a metallic plate(s) or adhesive pad(s) with connection cables. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290101363231 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry;Fragile