FDA UDI
In Commercial Distribution
🇺🇸 United States
Atlanta Healthcare Services OcuDrape®
DI: 10852171007480
·
Model: 10852171007480
·
ATLANTA HEALTHCARE SERVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
40
Basic Information
- Brand Name
- Atlanta Healthcare Services OcuDrape®
- Primary DI
- 10852171007480
- Version / Model
- 10852171007480
- Catalog Number
- DRA1021
- Company Name
- ATLANTA HEALTHCARE SERVICES, INC.
- Labeler DUNS
- 130599421
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 40
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2020-08-31
- Public Version Status
- Update
- Public Device Record Key
- 2ca0396c-c971-4f6e-baca-8772c208c216
Device Description
Ophthalmic Drape, Full Incise, Embossed Plastic 16 In. x 16 In.
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Radiation Sterilization", "Ethylene Oxide"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HMT | Drape, patient, ophthalmic | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46697 | Ophthalmic surgical drape | A protective covering made of natural or synthetic materials, or both, designed to promote a clean and dry sterile field about the eye during ophthalmic surgery or refractive and general ophthalmic office procedures. The device may be used to cover the eyebrow, retract lashes or eyelids, completely occlude the eyelid, or completely cover the eye. The device is typically secured directly to the skin with a pressure-sensitive adhesive, and is typically supplied sterile. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10852171007480 | GS1 | ||||
| Unit of Use | 00852171007483 | GS1 |
Customer Contacts
- Phone
- +1(404)812-9886
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K854613 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 16 | Inch | |
| Width | 16 | Inch |