FDA UDI
In Commercial Distribution
🇺🇸 United States
ASSUREPlus®
DI: D687830011
·
Model: 83001
·
Sultan Healthcare Inc
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
200
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- ASSUREPlus®
- Primary DI
- D687830011
- Version / Model
- 83001
- Company Name
- Sultan Healthcare Inc
- Labeler DUNS
- 056296981
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2019-11-08
- Public Version Status
- Update
- Public Device Record Key
- f18a9b27-42b4-4af7-84a0-2b04b8710978
Device Description
ASSUREPlus® Self-Sealing Sterilization Pouch 2.25 x 4 (57mm x 102mm) Box of 200
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
- 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 |
|---|---|---|---|---|
| KCT | Sterilization wrap containers, trays, cassettes & other accessories | General Hospital | 880.6850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13735 | Sterilization packaging, single-use | A device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | D6870083001FG2 | HIBCC | Case | 12 | In Commercial Distribution | |
| Primary | D687830011 | HIBCC | ||||
| Unit of Use | D687830010 | HIBCC |
Customer Contacts
- Phone
- +1(800)989-8825
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K953829 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 57mmx102mm | ||
| Width | 4 | Inch | |
| Length | 2.25 | Inch |