FDA UDI
In Commercial Distribution
🇺🇸 United States
Integra®
DI: 10381780086376
·
Model: 3734147
·
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Integra®
- Primary DI
- 10381780086376
- Version / Model
- 3734147
- Catalog Number
- 3734147
- Company Name
- INTEGRA LIFESCIENCES PRODUCTION CORPORATION
- Labeler DUNS
- 081277700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-24
- Public Version
- 4
- Public Version Date
- 2023-04-17
- Public Version Status
- Update
- Public Device Record Key
- b57de6c1-d427-4774-b0aa-c7e2e9017583
Device Description
Integra® Laryngeal Mirror, Stationary Octagonal Handle, Size 4, Diameter 20 mm
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KAI | MIRROR, ENT | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33431 | Laryngeal mirror, reusable | A hand-held manual surgical instrument with a mirror or a surface sufficiently polished to reflect enough undiffused light to form a virtual image of an object placed before it at the distal end, intended to be used for a laryngeal examination. The mirror is affixed at an angle to a long, slender shaft with a handle at the proximal end that is held by the doctor who can manipulate the mirror close to the site of interest in the throat. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10381780086376 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 6-3/4" | ||
| Outer Diameter | 20 | Millimeter |