DV8® Retractor

FDA UDI

Class I (US FDA UDI)

by Manual Surgical Sciences, L. L. C.

Identity

Trade Name: DV8® Retractor FDA UDI
Generic Name: Intraluminal oesophageal retractor FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 11075150 FDA UDI
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. FDA UDI

Identifiers

Catalog Number: 11075150 FDA UDI
Primary DI / UDI-DI: 00860222000413 FDA UDI
FDA Product Code: GAD FDA UDI
GMDN Term: Intraluminal oesophageal retractor FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Balloon Diameter — 11 Millimeter FDA UDI
Balloon Length — 230 Millimeter FDA UDI

Category: Intraluminal oesophageal retractor

DV8® Retractor by Manual Surgical Sciences, L. L. C. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intraluminal oesophageal retractor.

EsoSure — NORTHEAST SCIENTIFIC, INC. · Class I
EsoSure — NORTHEAST SCIENTIFIC, INC. · Class I
DV8® Retractor — Manual Surgical Sciences, L. L. C. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Manual Surgical Sciences, L. L. C.

Sources (1)

FDA UDI ab99ce34-2747-4478-bb7a-d5707dd43121 35 fields · synced May 30, 2026