← Back to catalogue

Endodrape®

FDA UDI

Class II (US FDA UDI)

by Vortek Surgical, LLC

Identity

Trade Name
ENDODRAPE® FDA UDI
Generic Name
Patient surgical drape, single-use, non-sterile FDA UDI
Device Name
ENDODRAPE® Colonoscopy w/o ScopeGuard, 49"x 52" FDA UDI
Model / Reference
2 FDA UDI
Description
ENDODRAPE® Colonoscopy w/o ScopeGuard, 49"x 52" FDA UDI

Identifiers

Catalog Number
68857 FDA UDI
Primary DI / UDI-DI
B27810689076068857 FDA UDI
510(k) Number
K070406 FDA UDI
FDA Product Code
KKX FDA UDI
GMDN Term
Patient surgical drape, single-use, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4370 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Patient surgical drape, single-use, non-sterile

Endodrape® by Vortek Surgical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient surgical drape, single-use, non-sterile.

Cleared under the same submission

K070406 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Vortek Surgical, LLC

Sources (1)

  • FDA UDI 7c3fb58e-96f3-4591-8b1c-fc553f500cf3 35 fields · synced Jun 1, 2026