FDA UDI
In Commercial Distribution
🇺🇸 United States
ENDOPATH
DI: 10705036000372
·
Model: 10BB
·
ETHICON ENDO-SURGERY, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ENDOPATH
- Primary DI
- 10705036000372
- Version / Model
- 10BB
- Catalog Number
- 10BB
- Company Name
- ETHICON ENDO-SURGERY, LLC
- Labeler DUNS
- 044606982
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-15
- Public Version
- 4
- Public Version Date
- 2021-11-12
- Public Version Status
- Update
- Public Device Record Key
- aede00b5-b2e5-4df6-aef1-39dd758b8e34
Device Description
10 mm Babcocks with Ratchet Handles
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
- 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 |
|---|---|---|---|---|
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61839 | Rigid endoscopic tissue manipulation forceps, single-use | A rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30705036000376 | GS1 | CASE | 36 | In Commercial Distribution | |
| Primary | 10705036000372 | GS1 | ||||
| Package | 20705036000379 | GS1 | BOX | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(877)384-4266
- [email protected]