FDA UDI
In Commercial Distribution
🇺🇸 United States
ITS Model-L6K
DI: 08800033200048
·
Model: ITSLC1811, ITSLC1821
·
InTheSmart Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ITS Model-L6K
- Primary DI
- 08800033200048
- Version / Model
- ITSLC1811, ITSLC1821
- Company Name
- InTheSmart Co., Ltd.
- Labeler DUNS
- 694495825
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-11
- Public Version
- 1
- Public Version Date
- 2022-11-21
- Public Version Status
- New
- Public Device Record Key
- f6a8eddd-511e-47a3-9f4d-77065455a03b
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| FWL | Camera, Cine, Endoscopic, Without Audio | General, Plastic Surgery | 878.4160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32259 | Endoscope cine camera | An electro-optical device that is designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to obtain moving-picture documentation of endoscopic findings and procedures. It typically consists of a lightproof chamber with an aperture fitted with a lens and a shutter, through which the image of an object is projected onto a surface for recording. It records a sequence of photographs and usually projects them sequentially to obtain a motion picture. The device may also include audio recording capabilities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800033200048 | GS1 |