FDA UDI
In Commercial Distribution
🇺🇸 United States
HANK DILATOR DOUBLE ENDED 7/8 FR
DI: G422DL3000
·
Model: DL300
·
BIOPSY FINE CUT INSTRUMENTS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- HANK DILATOR DOUBLE ENDED 7/8 FR
- Primary DI
- G422DL3000
- Version / Model
- DL300
- Catalog Number
- DL300
- Company Name
- BIOPSY FINE CUT INSTRUMENTS
- Labeler DUNS
- 645680898
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-13
- Public Version
- 1
- Public Version Date
- 2023-10-23
- Public Version Status
- New
- Public Device Record Key
- 6b2b4c23-4edf-42c7-a0e3-e2dbbc2fed7b
Device Description
HANK DILATOR DOUBLE ENDED 7/8 FR
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
- No
- 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 |
|---|---|---|---|---|
| KCF | Dilator, Esophageal, Ent | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13644 | Uterine sound, reusable | A hand-held manual instrument designed to measure and/or explore the internal depth or length of the uterus, cervix, and/or vagina. It is a slender hollow or solid cylindrical instrument made of metal or plastic typically with graduations of length displayed along its working end. It is typically available in a range of sizes and flexibilities. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G422DL3000 | HIBCC |