FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Covidien
DI: B504B5SHF0
·
Model: B5SHF
·
Provision
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Covidien
- Primary DI
- B504B5SHF0
- Version / Model
- B5SHF
- Company Name
- Provision
- Labeler DUNS
- 016889401
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-15
- Public Version
- 4
- Public Version Date
- 2024-11-26
- Public Version Status
- Update
- Public Device Record Key
- 48edaa95-649b-4b1b-ae19-7609acda73f6
- Distribution End Date
- 2024-11-25
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
- Yes
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| NLM | Laparoscope, General & Plastic Surgery, Reprocessed | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61813 | Laparoscopic access cannula, reprocessed | A sterile, single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is often provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall. It is available in a variety of dimensions and/or designs. This is a previously used single-use device that has been processed for an additional single-use patient application. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B504B5SHF0 | HIBCC | ||||
| Package | B504B5SHF1 | HIBCC | box | 6 | Not in Commercial Distribution | 2024-11-25 |
Customer Contacts
- Phone
- 541-422-8880
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172097 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 7 – 32 Degrees Celsius