FDA UDI
In Commercial Distribution
🇺🇸 United States
TenderTrode Plus™
DI: 10813150020579
·
Model: A10008
·
GRAPHIC CONTROLS ACQUISITION CORP
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- TenderTrode Plus™
- Primary DI
- 10813150020579
- Version / Model
- A10008
- Catalog Number
- A10008
- Company Name
- GRAPHIC CONTROLS ACQUISITION CORP
- Labeler DUNS
- 002111896
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2018-03-02
- Public Version
- 2
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- c5051d7b-79a3-421a-9ab3-068d9d9306f5
Device Description
Thermal Probe Cover 20/pouch, 10 pouches/case, 500 per case
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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMT | Warmer, Infant Radiant | General Hospital | 880.5130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33878 | Cable/lead/sensor/probe cover, non-sterile | A non-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 to protect the contents from soiling and contamination so that the non-sterile contents may be used in the vicinity of, or enter into 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 |
|---|---|---|---|---|---|---|
| Package | 20813150020576 | GS1 | CASE | 10 | In Commercial Distribution | |
| Primary | 10813150020579 | GS1 | ||||
| Unit of Use | 00813150020572 | GS1 |
Customer Contacts
- Phone
- 1.800.669.6905
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K915831 | 000 |