FDA.report

Medline

Primary DI
20888277416144
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
ONB5STFR
Catalog number
ONB5STFR
Device description
ONB5STF @VERSAPORT V2 OPT BLADELESS 5 MM
Published
2023-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NLMLaparoscope, general & plastic surgery, reprocessed

Product Code Classifications

CodeDeviceSpecialtyClass
NLMLaparoscope, General & Plastic Surgery, ReprocessedGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20888277416144PackageGS16In Commercial Distribution
10888277416147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088827741614420888277416144
1088827741614710888277416147

GMDN Terms

TermDefinition
Laparoscopic access cannula, reprocessedA sterile, single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is often provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall. It is available in a variety of dimensions and/or designs. This is a previously used single-use device that has been processed for an additional single-use patient application.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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