FDA UDI
In Commercial Distribution
🇺🇸 United States
KOLPLAST
DI: 07898027908460
·
Model: ESCOVA PP/ESPATULA PLAST 25UN
·
Kolplast C I
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- KOLPLAST
- Primary DI
- 07898027908460
- Version / Model
- ESCOVA PP/ESPATULA PLAST 25UN
- Catalog Number
- TPCAP25
- Company Name
- Kolplast C I
- Labeler DUNS
- 903963889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-29
- Public Version
- 1
- Public Version Date
- 2023-12-07
- Public Version Status
- New
- Public Device Record Key
- c9a21a66-99ca-435b-ba3b-cbd6ca881a1c
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- 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 |
|---|---|---|---|---|
| HHT | Spatula, Cervical, Cytological | Obstetrics/Gynecology | 884.4530 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65196 | General specimen collection kit | A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered receptacle with or without an additive/medium [e.g., preservation solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07898027908460 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153128 | 000 |