FDA UDI
In Commercial Distribution
🇺🇸 United States
Aspen® Flexible Light Handle Adapter
DI: 00887761008366
·
Model: LT-9508MAI
·
ASPEN SURGICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Aspen® Flexible Light Handle Adapter
- Primary DI
- 00887761008366
- Version / Model
- LT-9508MAI
- Company Name
- ASPEN SURGICAL PRODUCTS, INC.
- Labeler DUNS
- 027680821
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-17
- Public Version
- 5
- Public Version Date
- 2021-03-04
- Public Version Status
- Update
- Public Device Record Key
- c829f20a-5fc5-42e2-9fbb-aa223140c547
Device Description
Intent to be used with Aspen Surgical Disposable light Handle covers.
Device Characteristics
- Single Use
- No
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| FTA | Light, surgical, accessories | General, Plastic Surgery | 878.4580 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37089 | Light source adaptor | A small connecting device designed to permit the connection of the devices that together deliver light to a work field from a light source. This device is used to connect together products of dissimilar manufacture and dimensions, e.g., a fibreoptic light cable of one manufacture to the light source of another. It may also be used at the instrument end. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10887761008363 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 00887761008366 | GS1 |
Customer Contacts
- Phone
- +1(616)698-7100
- [email protected]