FDA UDI
In Commercial Distribution
🇺🇸 United States
GAMMA FINDER®
DI: 10801741085182
·
Model: GMSLV001-10
·
Bard Peripheral Vascular, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- GAMMA FINDER®
- Primary DI
- 10801741085182
- Version / Model
- GMSLV001-10
- Catalog Number
- GMSLV001-10
- Company Name
- Bard Peripheral Vascular, Inc.
- Labeler DUNS
- 135057938
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 46dd4a4f-6d48-4b75-ab3f-138342d8e37e
Device Description
STERILE SLEEVE For Use With GAMMA FINDER®, 10 Pack
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| IZD | Probe, uptake, nuclear | Radiology | 892.1320 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43970 | Cable/lead/sensor/probe cover, sterile | A sterile device, typically made of disposable plastic, that forms a protective enclosure around its cable/lead, probe, sensor, or tube contents, making a hygienic barrier so that the non-sterile contents may enter a hygienic area, e.g., a sterile surgical field. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10801741085182 | GS1 | ||||
| Unit of Use | 00801741085185 | GS1 |
Customer Contacts
- Phone
- +1(800)321-4254
- [email protected]