FDA UDI
In Commercial Distribution
🇺🇸 United States
Greenwald Surgical Company, Inc.
DI: 10801334001483
·
Model: 51100-30
·
GRACE MANUFACTURING, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Greenwald Surgical Company, Inc.
- Primary DI
- 10801334001483
- Version / Model
- 51100-30
- Catalog Number
- U403
- Company Name
- GRACE MANUFACTURING, INC.
- Labeler DUNS
- 607903382
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2023-07-25
- Public Version Status
- Update
- Public Device Record Key
- 3ad15140-a760-4eda-aee0-f98490dcc7db
Device Description
Stamey Needle, 30 degree angled tip
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
- 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", "Liquid Chemical"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | Gastroenterology, Urology | 876.4730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47441 | Transvaginal needle, surgical | A hand-held manual surgical instrument with a sharp pyramidal or conical point designed to create a puncture in the vaginal wall for the surgical positioning of a sling typically used in the treatment of stress urinary incontinence (SUI) associated with bladder prolapse. The distal working end is typically made of a high-grade stainless steel curved rod with a pointed tip and an eye or notch to help position the sling. The proximal end can have a handle made of metal or durable plastic. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10801334001483 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 6.375 | Inch | |
| Angle | 30 | degree |