FDA UDI
Not in Commercial Distribution
🇺🇸 United States
DV8® Retractor
DI: 00860222000413
·
Model: 11075150
·
Manual Surgical Sciences, L. L. C.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- DV8® Retractor
- Primary DI
- 00860222000413
- Version / Model
- 11075150
- Catalog Number
- 11075150
- Company Name
- Manual Surgical Sciences, L. L. C.
- Labeler DUNS
- 117502037
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-13
- Public Version
- 2
- Public Version Date
- 2026-03-10
- Public Version Status
- Update
- Public Device Record Key
- ab99ce34-2747-4478-bb7a-d5707dd43121
- Distribution End Date
- 2025-05-19
Device Description
The DV8® Retractor Esophageal Balloon (DV8 Retractor) is a non-sterile, single-use, disposable esophageal balloon retractor. The DV8 Retractor is deployed orally and inflated inside the esophagus. The retractor gently and effectively retracts the esophagus to create a stable operating field.
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
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAD | Retractor | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62204 | Intraluminal oesophageal retractor | A hand-held manual instrument intended to be orally introduced into the oesophagus during thoracic surgery to mechanically divert the oesophagus away from the site of surgery, to facilitate surgical site access and to help prevent injury. It is available in a variety of forms (e.g., curved metal wire, metal rod with balloon). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860222000413 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Balloon Diameter | 11 | Millimeter | |
| Balloon Length | 230 | Millimeter |