FDA UDI
In Commercial Distribution
🇺🇸 United States
WALLACH
DI: 00888937013733
·
Model: SK-1085
·
Coopersurgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- WALLACH
- Primary DI
- 00888937013733
- Version / Model
- SK-1085
- Company Name
- Coopersurgical, Inc.
- Labeler DUNS
- 801895244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-18
- Public Version
- 5
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- eca4d156-fc3a-4c9a-8ea7-05ef0d77d24b
Device Description
Trulight ZoomScope®
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HEX | Colposcope (And Colpomicroscope) | Obstetrics/Gynecology | 884.1630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10960 | Colposcope | An electrically-powered instrument intended to be used for the visual examination and treatment of the female genitalia. It is placed directly at the opening of the vagina which is held open with an inserted speculum during colposcopy. The instrument has a light source and magnifying lenses that allow the physician to view the interior of the vagina, particularly the uterine cervix. This device is used to check for cervical cancer typically after an abnormal Papanicolaou test (PAP) or as a follow up procedure to view an abnormal area seen during an earlier gynaecological examination. During colposcopy, samples of tissue can be taken from the cervix for testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00888937013733 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K853389 | 000 |