FDA UDI
In Commercial Distribution
🇺🇸 United States
Halyard
DI: 20680651473398
·
Model: 47339
·
O&M HALYARD, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
250
Basic Information
- Brand Name
- Halyard
- Primary DI
- 20680651473398
- Version / Model
- 47339
- Catalog Number
- 47339
- Company Name
- O&M HALYARD, INC.
- Labeler DUNS
- 081057389
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 250
- Record Status
- Published
- Publish Date
- 2020-09-15
- Public Version
- 1
- Public Version Date
- 2020-09-23
- Public Version Status
- New
- Public Device Record Key
- fd45e71d-a15e-4802-a93b-78f2877ecac3
Device Description
STERLING SG* Nitrile Exam Glove ECO PULL*, XS
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
- 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
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| LZC | Patient examination glove, specialty | General Hospital | 880.6250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52286 | Leishmania donovani nucleic acid IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from the parasitic protozoan Leishmania donovani in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30680651473395 | GS1 | CS | 10 | In Commercial Distribution | |
| Primary | 20680651473398 | GS1 | ||||
| Unit of Use | 90680651473397 | GS1 |
Customer Contacts
- Phone
- +1(844)425-9273
- [email protected]