FDA UDI
In Commercial Distribution
🇺🇸 United States
Dinamic OR Gerstner Double Wide Orange Cover Labeled A1-A8
DI: 00869653000221
·
Model: 2000A-B
·
FLEX OPERATING ROOM, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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
- Dinamic OR Gerstner Double Wide Orange Cover Labeled A1-A8
- Primary DI
- 00869653000221
- Version / Model
- 2000A-B
- Catalog Number
- 2000A-B
- Company Name
- FLEX OPERATING ROOM, LLC
- Labeler DUNS
- 080180725
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 3
- Public Version Date
- 2018-12-10
- Public Version Status
- Update
- Public Device Record Key
- bbd5ccd0-f59b-448e-be7f-2ac9e61ff428
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KKX | Drape, Surgical | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45021 | Instrument/equipment drape, single-use, sterile | A sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various surgical and/or non-surgical instruments/equipment [e.g., surgical tray, operating room (OR) equipment table, endoscope and endoscopic instruments, surgical cameras and lasers], to provide a barrier against cross-contamination in various clinical settings. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10869653000228 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 00869653000221 | GS1 |
Customer Contacts
- Phone
- 585-635-7260
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101598 | 000 |