FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Exact Medical Manufacturing, Inc.
DI: 00852205007977
·
Model: EP54-150
·
EXACT MEDICAL MANUFACTURING, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Exact Medical Manufacturing, Inc.
- Primary DI
- 00852205007977
- Version / Model
- EP54-150
- Catalog Number
- EP54-150
- Company Name
- EXACT MEDICAL MANUFACTURING, INC.
- Labeler DUNS
- 014464314
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-06
- Public Version
- 2
- Public Version Date
- 2024-10-03
- Public Version Status
- Update
- Public Device Record Key
- c9abb60f-be38-42bd-8418-69a427963c3a
- Distribution End Date
- 2024-10-02
Device Description
Microscope Drape-Leica, Bayonet, 137x381cm - 54"x150"
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 |
|---|---|---|---|---|
| 12535 | Medical equipment/instrument drape, single-use | A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20852205007971 | GS1 | Outer Case | 1 | Not in Commercial Distribution | 2024-10-02 |
| Package | 10852205007974 | GS1 | Inner Case | 10 | Not in Commercial Distribution | 2024-10-02 |
| Primary | 00852205007977 | GS1 |
Customer Contacts
- Phone
- 716-681-0866
- [email protected]