Ancora

Primary DI
10860006600805
Brand
Ancora
Company
Aspero Medical, Inc.
Model
Ancora-SB 4-pack
Device description
Balloon Overtube Assembly, package of 4
Published
2023-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FDAEnteroscope And Accessories
FEDEndoscopic Access Overtube, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDAEnteroscope And AccessoriesGastroenterology, Urology2
FEDEndoscopic Access Overtube, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231323000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231323000Ancora-SBAspero Medical, Inc.2023-08-31FDA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860006600805PrimaryGS10
00860006600808Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000660080510860006600805
00860006600808008600066008088600066008080860006600808

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic overtube, single-useA tubular device intended to be used in combination with a compatible flexible endoscope to aid in endoscopic insertions and to secure a pathway for multiple endoscopic intubations during diagnostic and therapeutic endoscopic procedures (e.g., upper and/or lower gastrointestinal (GI) tract endoscopy). It is a non-steerable, typically single lumen tube constructed of plastic; some types may be "shape locked" into a desired configuration or form to assist in the repeated advancement and withdrawal of the endoscope (e.g., for the removal of multiple polyps and/or foreign bodies). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081317957
Device count
4
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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