FDA UDI
In Commercial Distribution
🇺🇸 United States
Sklar Instruments
DI: 10649111493164
·
Model: 96-2210A
·
SKLAR CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Sklar Instruments
- Primary DI
- 10649111493164
- Version / Model
- 96-2210A
- Company Name
- SKLAR CORPORATION
- Labeler DUNS
- 006966006
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-03
- Public Version
- 2
- Public Version Date
- 2025-02-12
- Public Version Status
- Update
- Public Device Record Key
- 87eef995-b520-47b5-ac8d-dfc6c7b09c16
Device Description
ECONO STERILE WEITLANER RETR 3X4 BL 8" CS/10
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FFO | RETRACTOR, SELF-RETAINING | Gastroenterology, Urology | 876.4730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65652 | Multiple-type respiratory pathogen immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to multiple types of respiratory pathogens (e.g., viruses and bacteria) in a clinical specimen, using a fluorescent immunoassay method. Organisms intended to be detected may include Legionella pneumophila, Mycoplasma pneumoniae, Coxiella burnetiid, Chlamydophila pneumoniae, respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, and/or adenovirus. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50649111493162 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 10649111493164 | GS1 |