FDA UDI
In Commercial Distribution
🇺🇸 United States
Simplastic
DI: H66809216711
·
Model: 0921671
·
Keystone Industries
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2000
Basic Information
- Brand Name
- Simplastic
- Primary DI
- H66809216711
- Version / Model
- 0921671
- Catalog Number
- 0921671
- Company Name
- Keystone Industries
- Labeler DUNS
- 073503117
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2000
- Record Status
- Published
- Publish Date
- 2022-11-30
- Public Version
- 1
- Public Version Date
- 2022-12-08
- Public Version Status
- New
- Public Device Record Key
- 70a69a25-15b5-4669-a339-0c3497ffd367
Device Description
SIMPLASTIC SLEEVE (2000)- Barrier Item
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
- 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
- No
- 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 |
|---|---|---|---|---|
| NRD | Unit, operative dental, accessories | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12535 | Medical equipment drape, single-use | A 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 neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | H66809216710 | HIBCC | ||||
| Primary | H66809216711 | HIBCC |
Customer Contacts
- Phone
- +1(800)333-3131 ext. 8455
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of direct sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from moisture