FDA UDI
In Commercial Distribution
🇺🇸 United States
Atlanta Healthcare Services OcuDrape®
DI: 10852171007633
·
Model: 10852171007633
·
ATLANTA HEALTHCARE SERVICES, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
250
Basic Information
- Brand Name
- Atlanta Healthcare Services OcuDrape®
- Primary DI
- 10852171007633
- Version / Model
- 10852171007633
- Catalog Number
- OPH507NS
- Company Name
- ATLANTA HEALTHCARE SERVICES, INC.
- Labeler DUNS
- 130599421
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 250
- Record Status
- Published
- Publish Date
- 2016-11-14
- Public Version
- 3
- Public Version Date
- 2020-08-31
- Public Version Status
- Update
- Public Device Record Key
- 18381cfc-8ac9-4b7c-8dfd-03addebe42a2
Device Description
Suture Bag-Utility Cover, Clear Plastic 8x15" with Tape Strip & Gusset
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Ethylene Oxide", "Radiation Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KKX | Drape, surgical | General, Plastic Surgery | 878.4370 | 2 |
| PUI | Drape, Surgical, Exempt | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12535 | Medical equipment drape, single-use | A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. 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 |
|---|---|---|---|---|---|---|
| Primary | 10852171007633 | GS1 | ||||
| Unit of Use | 00852171007636 | GS1 |
Customer Contacts
- Phone
- +1(404)812-9886
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 8 | Inch | |
| Length | 15 | Inch |