FDA UDI
In Commercial Distribution
🇺🇸 United States
ORDOCK CUP, DISPOSABLE
DI: B99214101010
·
Model: 14-101-01
·
JB Medical Development, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ORDOCK CUP, DISPOSABLE
- Primary DI
- B99214101010
- Version / Model
- 14-101-01
- Catalog Number
- 1410101
- Company Name
- JB Medical Development, LLC
- Labeler DUNS
- 873149871
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-18
- Public Version
- 3
- Public Version Date
- 2023-05-03
- Public Version Status
- Update
- Public Device Record Key
- 5d74a2f6-57bf-432d-87c2-7b0225c2898d
Device Description
A SINGLE, STERILE CUP THAT ATTACHES TO A PLATFORM (NOT INCLUDED) TO HOLD INSTRUMENTS DURING A SURGICAL PROCEDURE. THIS CUP IS SOLD SINGLY TO ACCOMMODATE HOSPITALS WHO WISH TO BUY IN BULK. HOWEVER TWO CUPS ARE REQUIRED TO BE ATTACHED TO THE PLATFORM WHEN IT IS BEING USED.
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
- 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 |
|---|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12236 | Surgical instrument interim-placement holder, single-use | A device intended to be used in the operating room (OR) by staff to safely hold a hand-held, manual, surgical instrument(s) [e.g., needle, scalpel, scissors, robotic system instrument hand-held remote controller] when not in use during surgery, to avoid damage to the instrument, maintain its sterility, and/or for temporary storage (e.g., to enable easy transfer/handling of the instrument at reduced risk of injury). It is available in various forms (e.g., rack, puncture cushion, telescopic tube, magnetic mat), and may be attached to a surgical drape; it is not a numbered tray and is not intended for counting of sharps. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B99214101010 | HIBCC |
Customer Contacts
- Phone
- 18776036333
- [email protected]