FDA UDI
In Commercial Distribution
🇺🇸 United States
Medpor
DI: 07613327292336
·
Model: 92-7241-2
·
Stryker Leibinger GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Medpor
- Primary DI
- 07613327292336
- Version / Model
- 92-7241-2
- Catalog Number
- 92-7241-2
- Company Name
- Stryker Leibinger GmbH & Co. KG
- Labeler DUNS
- 316153956
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-08
- Public Version
- 5
- Public Version Date
- 2020-12-21
- Public Version Status
- Update
- Public Device Record Key
- 41c214a2-4edb-4165-aaaf-a53692a6e5e3
Device Description
Nostril Retainer Asymmetric - R4-L3
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LYA | SPLINT, INTRANASAL SEPTAL | Ear, Nose, Throat | 874.4780 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31919 | Intranasal splint, non-biodegradable | A non-biodegradable device intended to be temporarily placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and/or provide support to the surrounding tissues during the healing period. It is typically made of plastic, silicone, and/or a blood/liquid absorptive material and is removed at the discretion of the physician. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613327292336 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K981374 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Diameter: 8.13 Millimeter | ||
| Width | 19.4 | Millimeter | |
| Length | 25.0 | Millimeter | |
| Device Size Text, specify | Diameter: 9.04 Millimeter |