FDA UDI
In Commercial Distribution
🇺🇸 United States
Hoopla Retractor
DI: 00810032660451
·
Model: CIR0101
·
ZYRIS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- Hoopla Retractor
- Primary DI
- 00810032660451
- Version / Model
- CIR0101
- Catalog Number
- CIR0101
- Company Name
- ZYRIS, INC.
- Labeler DUNS
- 068038277
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2024-04-08
- Public Version
- 2
- Public Version Date
- 2024-04-22
- Public Version Status
- Update
- Public Device Record Key
- 50eaa9c4-e0cf-4cfd-8fbb-bc99640249f0
Device Description
Hoopla Retractor, One Size, 10-Pack, EDU
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EIF | ACCESSORIES, RETRACTOR, DENTAL | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13380 | Hand-held dental retractor | A hand-held, non-self-retaining dental instrument intended to be used to manually displace soft tissues of the oral cavity to improve their visualization and access, and to afford them protection during oral surgical procedures. It is typically a metallic device and includes a shaped/hooked blade with a handle/holding portion. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10810032660458 | GS1 | ||||
| Primary | 00810032660451 | GS1 |
Customer Contacts
- Phone
- +1(800)560-6066
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius