FDA UDI
In Commercial Distribution
🇺🇸 United States
Acu-Health
DI: 00079573103432
·
Model: 400343/400343A/400343PU
·
APOTHECARY PRODUCTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
6
Pkg Device Count
40
Basic Information
- Brand Name
- Acu-Health
- Primary DI
- 00079573103432
- Version / Model
- 400343/400343A/400343PU
- Company Name
- APOTHECARY PRODUCTS, LLC
- Labeler DUNS
- 092312735
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 40
- Record Status
- Published
- Publish Date
- 2020-08-12
- Public Version
- 1
- Public Version Date
- 2020-08-20
- Public Version Status
- New
- Public Device Record Key
- f5745717-096c-4caf-ae1b-66a9eb050046
Device Description
FINGER PROTECTORS 40 PACK CTN/PUBLIX FINGER COTS 40CT
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | 878.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31978 | Finger-cot surgical drape | A protective covering made of latex designed to isolate a urological/gynaecological surgical site from contamination (e.g., microbial, substance), that has a projection (finger cot) retained within the rectum or vagina to allow repeated insertion of the surgeon's finger into the rectum (e.g., during a transurethral prostatectomy) or vagina, keeping the glove of the surgeon from being contaminated. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10079573103439 | GS1 | Box | 12 | In Commercial Distribution | |
| Primary | 00079573103432 | GS1 | ||||
| Package | 20079573103436 | GS1 | Case | 12 | In Commercial Distribution | |
| Package | 20079573000353 | GS1 | Bag | 6 | In Commercial Distribution | |
| Package | 10079573000318 | GS1 | Case | 24 | In Commercial Distribution | |
| Unit of Use | 40079573103430 | GS1 |
Customer Contacts
- Phone
- 952-890-1940
- [email protected]