FDA UDI
In Commercial Distribution
🇺🇸 United States
Biosphere® screw cap, yellow
DI: 04038917277754
·
Model: 65.716.202
·
Sarstedt Aktiengesellschaft & Co.KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
500
Basic Information
- Brand Name
- Biosphere® screw cap, yellow
- Primary DI
- 04038917277754
- Version / Model
- 65.716.202
- Catalog Number
- 65.716.202
- Company Name
- Sarstedt Aktiengesellschaft & Co.KG
- Labeler DUNS
- 388000270
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2022-11-30
- Public Version
- 1
- Public Version Date
- 2022-12-08
- Public Version Status
- New
- Public Device Record Key
- 09d730cb-d835-46d7-ac32-bc180f90385b
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
- Yes
- 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 |
|---|---|---|---|---|
| KDT | CONTAINER, SPECIMEN MAILER AND STORAGE, STERILE | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66068 | Test tube/reservoir cap IVD | A covering intended to be used to seal the top of an in vitro diagnostic test tube or reagent reservoir to protect the contents against contamination from the external environment, and to prevent spillage and/or evaporation of contents during transportation or processing. The top of the cap may be penetrable to enable injection or aspiration of contents. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 04038917277761 | GS1 | ||||
| Primary | 04038917277754 | GS1 |
Customer Contacts
- Phone
- +1(800)257-5101
- [email protected]