FDA UDI
Not in Commercial Distribution
🇺🇸 United States
HNM MEDICAL
DI: 00842962106488
·
Model: HBI-RD003
·
HNM STAINLESS, LLC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HNM MEDICAL
- Primary DI
- 00842962106488
- Version / Model
- HBI-RD003
- Catalog Number
- HBI-RD003
- Company Name
- HNM STAINLESS, LLC.
- Labeler DUNS
- 806754185
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-01
- Public Version
- 2
- Public Version Date
- 2023-12-08
- Public Version Status
- Update
- Public Device Record Key
- 9860e6b8-f108-4a4b-88a1-a57d8958bde9
- Distribution End Date
- 2023-12-07
Device Description
CURETTE ENDOMETRIAL SAMPLER W/TWIST AND LOCK SYRINGE, 3MM, BOX OF 25
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46870 | Intrauterine scoop | A heavy, hand-held, manual surgical instrument with a spoon-like, sharp-edged distal end on a long shaft that is used to access and scrape (gouge or scoop out) a particular area of the lining of the uterus for its removal during a gynaecological procedure. The device is rigid and typically made of high-grade stainless steel. The scoop at the distal end is available in various shapes and sizes; there is a handle at the proximal end. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842962106488 | GS1 |