FDA UDI
In Commercial Distribution
🇺🇸 United States
Integra®
DI: 10381780527015
·
Model: 3405431
·
INTEGRA PAIN MANAGEMENT
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Integra®
- Primary DI
- 10381780527015
- Version / Model
- 3405431
- Catalog Number
- 3405431
- Company Name
- INTEGRA PAIN MANAGEMENT
- Labeler DUNS
- 030370299
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-05
- Public Version
- 2
- Public Version Date
- 2019-07-22
- Public Version Status
- Update
- Public Device Record Key
- dbb37ff8-046c-4890-a016-f83827d5f78a
Device Description
Single Shot Epidural Tray
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| CAZ | Anesthesia conduction kit | Anesthesiology | 868.5140 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61911 | Epidural anaesthesia set, medicated | A collection of devices intended for the administration of an analgesic or anaesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anaesthetic agent and a needle, with additional devices utilized for the procedure (e.g., syringe, dressings), and may include a catheter (i.e., may be intended for single- or continuous-administration). It is not intended for intrathetcal anaesthesia. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | 10381780511175 | GS1 | ||||
| Package | 30381780527019 | GS1 | Case | 20 | In Commercial Distribution | |
| Primary | 10381780527015 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K945484 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 68 – 77 Degrees Fahrenheit