FDA UDI
In Commercial Distribution
🇺🇸 United States
Hygienic Sheath
DI: 40192155942507
·
Model: Hygienic Sheath
·
CARESTREAM DENTAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
200
Basic Information
- Brand Name
- Hygienic Sheath
- Primary DI
- 40192155942507
- Version / Model
- Hygienic Sheath
- Catalog Number
- 5942503
- Company Name
- CARESTREAM DENTAL LLC
- Labeler DUNS
- 019796106
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2019-12-13
- Public Version
- 1
- Public Version Date
- 2019-12-23
- Public Version Status
- New
- Public Device Record Key
- 449208a2-fe01-4eac-a559-8b098c7e154d
Device Description
HYGIENIC SHEATHS #0 - 200 PCS
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 |
|---|---|---|---|---|
| KQM | Camera, Surgical And Accessories | General, Plastic Surgery | 878.4160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63712 | Medical equipment drape, single-use, non-sterile | A non-sterile flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is not a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 60192155942501 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 40192155942507 | GS1 | ||||
| Unit of Use | 00192155942509 | GS1 |