FDA UDI
In Commercial Distribution
🇺🇸 United States
Exact Memdical Manufacturing
DI: 00852205007960
·
Model: EP54-120
·
EXACT MEDICAL MANUFACTURING, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Exact Memdical Manufacturing
- Primary DI
- 00852205007960
- Version / Model
- EP54-120
- Catalog Number
- EP54-120
- Company Name
- EXACT MEDICAL MANUFACTURING, INC.
- Labeler DUNS
- 014464314
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-06
- Public Version
- 1
- Public Version Date
- 2018-10-08
- Public Version Status
- New
- Public Device Record Key
- 9c622bb2-1d13-4ffe-a636-b8e963fa4b0f
Device Description
Microscope Drape-Leica, Bayonet, 137x305cm - 54"x120"
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
- 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 | 20852205007964 | GS1 | Outer Case | 1 | In Commercial Distribution | |
| Package | 10852205007967 | GS1 | Inner Case | 10 | In Commercial Distribution | |
| Primary | 00852205007960 | GS1 |
Customer Contacts
- Phone
- 716-681-0866
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101689 | 000 |