FDA UDI
In Commercial Distribution
🇺🇸 United States
N.A.
DI: J011772113010
·
Model: 772-113-01
·
DENTAURUM GmbH & Co.KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3000
Basic Information
- Brand Name
- N.A.
- Primary DI
- J011772113010
- Version / Model
- 772-113-01
- Company Name
- DENTAURUM GmbH & Co.KG
- Labeler DUNS
- 315427286
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3000
- Record Status
- Published
- Publish Date
- 2024-06-20
- Public Version
- 1
- Public Version Date
- 2024-06-28
- Public Version Status
- New
- Public Device Record Key
- e11e910a-c0a9-4d47-8892-91c79a39648d
Device Description
Intra-oral latex elastics, medium, ø 3.2 mm
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 41677 | Orthodontic archwire/bracket ligature | A device intended to securely tether an orthodontic archwire to an orthodontic bracket, or securely hold the archwire in the archwire slot of an orthodontic bracket (or brace). It is in the form of a small single tie, or a circular band made of elastomeric (e.g., polyurethane, rubber) or metal materials. 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 |
|---|---|---|---|---|---|---|
| Unit of Use | J011772113011 | HIBCC | ||||
| Primary | J011772113010 | HIBCC |
Customer Contacts
- Phone
- +1(800)523-3946
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K935144 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- No special storage conditions required