FDA UDI
In Commercial Distribution
🇺🇸 United States
ENCHANTED™ SERIES
DI: 10190886033210
·
Model: 14HVAC
·
G & H Wire Company, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- ENCHANTED™ SERIES
- Primary DI
- 10190886033210
- Version / Model
- 14HVAC
- Company Name
- G & H Wire Company, Inc.
- Labeler DUNS
- 831465641
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2023-10-09
- Public Version
- 1
- Public Version Date
- 2023-10-17
- Public Version Status
- New
- Public Device Record Key
- c316625b-abc5-496c-a963-b2403199cebe
Device Description
ENCHANTED SER COL 1/4 HV ELAST
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- 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 |
|---|---|---|---|---|
| ECI | Band, Elastic, Orthodontic | Dental | 872.5410 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62074 | Orthodontic inter-arch elastic band | A non-sterile circular band intended to be used during orthodontic treatment to exert a continuous light force to adjust bite and jaw position for correcting malocclusions (e.g., overbite, underbite). It is made of an elastomeric material (e.g., polyurethane, rubber) and is secured to hooks on orthodontic brackets across non-opposing mandibular and maxillary teeth. This is a single-patient device intended to be replaced regularly during orthodontic treatment (single-use). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20190886033217 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 10190886033210 | GS1 | ||||
| Unit of Use | 00190886033213 | GS1 |
Customer Contacts
- Phone
- +1 317-346-6655
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | .25 | Inch | |
| Device Size Text, specify | Force - 6.5 ounces |