FDA UDI
In Commercial Distribution
🇺🇸 United States
Endocraft LLC
DI: 00860009975132
·
Model: ZVG100A
·
Endocraft, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Endocraft LLC
- Primary DI
- 00860009975132
- Version / Model
- ZVG100A
- Catalog Number
- ZVG100A
- Company Name
- Endocraft, LLC
- Labeler DUNS
- 039432148
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-07
- Public Version
- 1
- Public Version Date
- 2023-07-17
- Public Version Status
- New
- Public Device Record Key
- 916d43d4-8f9d-44f9-8b7c-4afa28b9c74e
Device Description
Zeitels Suspension Gallows positions and holds the laryngoscope and patient in ideal posture for surgery. This suspension mounts to the surgical bed, rather than on the patient's chest.
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CCW | Laryngoscope, Rigid | Anesthesiology | 868.5540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66249 | Rigid laryngoscope positioner | A noninvasive device designed to externally hold and position a rigid laryngoscope on the chest of a patient during an examination or intervention. It consists of a sturdy rod, a laryngoscope connector at one end, and a rubber base at the other end for placement on the patient’s chest to provide support and facilitate alignment of the laryngoscope relative to the patient’s body. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860009975132 | GS1 |
Customer Contacts
- Phone
- 401-369-7344
- [email protected]