FDA UDI
In Commercial Distribution
🇺🇸 United States
McKesson
DI: 20612479202140
·
Model: 543
·
MCKESSON MEDICAL-SURGICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
35
Basic Information
- Brand Name
- McKesson
- Primary DI
- 20612479202140
- Version / Model
- 543
- Company Name
- MCKESSON MEDICAL-SURGICAL INC.
- Labeler DUNS
- 023904428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 35
- Record Status
- Published
- Publish Date
- 2016-12-09
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 2ed3cac4-faee-4626-84db-b0ce206f7507
Device Description
BIOPSY SAMPLER (ENDOMETRIAL CELL SAMPLER)
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
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HHK | Curette, Suction, Endometrial (And Accessories) | Obstetrics/Gynecology | 884.1175 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46871 | Endometrial biopsy curette | A hand-held, surgical instrument used to for the removal of small amounts of endometrial secretions and/or tissue from the uterus for biopsy purposes. It is typically made of high-grade stainless steel and is available in a variety of designs: 1) a long, thin, instrument with very small spoon-like scoop terminating at either end and a centrally placed handle; 2) a long, thin tubular device with a serrated opening at the distal end and a connection to a suction device or a syringe at the proximal end; or 3) a single-ended device with a scraper at the distal end. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20612479202140 | GS1 | ||||
| Unit of Use | 10612479218120 | GS1 | ||||
| Package | 40612479202151 | GS1 | Case | 6 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K102847 | 000 |