FDA UDI
In Commercial Distribution
🇺🇸 United States
Jigsaw Medical, LLC
DI: 00856274008064
·
Model: 50116-S
·
JIGSAW MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Jigsaw Medical, LLC
- Primary DI
- 00856274008064
- Version / Model
- 50116-S
- Catalog Number
- 50116-S
- Company Name
- JIGSAW MEDICAL, LLC
- Labeler DUNS
- 079233827
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-19
- Public Version
- 2
- Public Version Date
- 2020-02-06
- Public Version Status
- Update
- Public Device Record Key
- ffc65774-1858-431d-a15e-555f8e80a411
Device Description
Endoscopic Triangle Knife
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
- Yes
- 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 |
|---|---|---|---|---|
| NBH | Accessories, Arthroscopic | Orthopedic | 888.1100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47569 | Scalpel, single-use | A hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00856274008248 | GS1 | Case | 6 | In Commercial Distribution | |
| Primary | 00856274008064 | GS1 |