FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 00810047420033
·
Model: 267
·
Scientific Device Laboratory, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 00810047420033
- Version / Model
- 267
- Company Name
- Scientific Device Laboratory, Inc.
- Labeler DUNS
- 115927956
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-30
- Public Version
- 1
- Public Version Date
- 2023-02-07
- Public Version Status
- New
- Public Device Record Key
- 5ae0d9f1-d3f6-48d3-b269-a497ee3ca3c8
Device Description
Shrink Seals 16 X 15 [1,000 seals/pkg]
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61305 | Assay adhesive sealing/fixation film IVD | A thin adhesive film intended to be used during in vitro diagnostic assays typically to seal the top of a microplate to prevent sample carryover and/or evaporation, and/or to fix test strips to a surface/chart to facilitate analysis. It is typically made of aluminium foil or plastic. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810047420033 | GS1 |