FDA UDI
In Commercial Distribution
🇺🇸 United States
Furlow
DI: 00191506022181
·
Model: M00635400020
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Furlow
- Primary DI
- 00191506022181
- Version / Model
- M00635400020
- Catalog Number
- M00635400020
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-18
- Public Version
- 2
- Public Version Date
- 2023-08-04
- Public Version Status
- Update
- Public Device Record Key
- 309e2221-97d4-4d4a-89fe-3a2051e1e64d
Device Description
Disposable Insertion Tool
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| QGA | Penile implant surgical accessories | Gastroenterology, Urology | 876.3500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60798 | Penile prosthesis implantation instrument | A sterile, hand-held manual surgical instrument intended to be used to implant a penile prosthesis (e.g., penile prosthesis cylinder insertion within the corpora cavernosa). It may also be used during revision surgery of a penile prosthesis; it has no general surgical application. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00191506022181 | GS1 |