FDA UDI
In Commercial Distribution
🇺🇸 United States
Non-Sterile Latex Finger Cots
DI: 10841912104243
·
Model: 3001
·
PROTEK MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- Non-Sterile Latex Finger Cots
- Primary DI
- 10841912104243
- Version / Model
- 3001
- Catalog Number
- 3001
- Company Name
- PROTEK MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 965417181
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- f498e797-d97f-432d-a0b3-0b83ac42de1e
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 10841912104243 | GS1 | ||||
| Unit of Use | 00841912104246 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K970891 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight