FDA UDI
In Commercial Distribution
🇺🇸 United States
Atlanta Healthcare Services OcuDrape®
DI: 10851736007705
·
Model: 10851736007705
·
ATLANTA HEALTHCARE SERVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
500
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
- Atlanta Healthcare Services OcuDrape®
- Primary DI
- 10851736007705
- Version / Model
- 10851736007705
- Catalog Number
- AHS550NS
- Company Name
- ATLANTA HEALTHCARE SERVICES, INC.
- Labeler DUNS
- 130599421
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- 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
- f0acebc4-af1a-4bc2-860f-9db0f8f6a7eb
Device Description
Fluid Pouch 500cc 12" wide x 7" deep, 12" x 1-1/2" adhesive tape, forming bar
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
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide, Radiation Sterilization
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 |
|---|---|---|---|---|
| 58982 | Surgical tissue/fluid collection bag, non-sterile | A non-sterile flexible container (a pouch) designed to be attached adjacent to a site of surgical intervention to collect and store body fluids, tissue, or body parts (e.g., a limb) released during the procedure. It is typically constructed as a pouch made of plastic foils with an adhesive band for attachment (e.g., next to the patient's skin incision or on the sterile drape), is available in a variety of sizes, and may be equipped with a fluid filter. This device is not intended to connect to an active drainage system or suction system but relies on gravity for fluid collection. This is a single-use device intended to be sterilized prior to use. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10851736007705 | GS1 | ||||
| Unit of Use | 00851736007708 | 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 | 7 | Inch | |
| Width | 12 | Inch |