FDA.reportPublic FDA data

Pretzelflex - Surgical Retraction System

Primary DI
05051986008561
Brand
Pretzelflex - Surgical Retraction System
Company
SURGICAL INNOVATIONS LIMITED
Model
SHR7001
Device description
5mm Pretzelflex Retractor
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123110000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123110000PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301Surgical Innovations Plc2013-01-17GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051986008561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051986008561050519860085615051986008561

GMDN Terms#

Term, Definition table
TermDefinition
Externally-anchored laparoscopic retractorA non-sterile, intraoperative surgical instrument designed for use during laparoscopic procedures to provide hands-free retraction of lower abdominal, urogenital or pelvic structures. It is inserted into the abdominal cavity through a small dedicated incision and manoeuvred into place under direct laparoscopic vision to lift the urogenital structures, and then anchored external to the body to a fixation device typically attached to the operating table. It is typically made of metal (e.g., stainless steel) and is in the form of a rod shaped to form a saddle-shaped hook, and may be available in left and right configurations. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
771051935
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05051986013503YelloPort Elite - Laparoscopic Port Access SystemET05055092025-03-11
05051986013510YelloPort Elite - Laparoscopic Port Access SystemET05070092025-03-11
05051986013527YelloPort Elite - Laparoscopic Port Access SystemET05095092025-03-11
05051986013572YelloPort Elite - Laparoscopic Port Access SystemEC13075202024-08-29
05051986013589YelloPort Elite - Laparoscopic Port Access SystemEC13105202024-08-29
05051986013596YelloPort Elite - Laparoscopic Port Access SystemEC13150202024-08-29
05051986001357YelloPort PlusYA516STS2016-09-23
05051986001562YelloPort Elite - Laparoscopic Port Access SystemEA512US2020-10-08
05051986002323YelloPort Plus - Laparoscopic Port Access SystemYA03VSS022020-10-08
05051986012537YelloPort Plus - Laparoscopic Port Access SystemYA03VSS032020-10-08
05051986013077YelloPort Elite EA05XL2022-04-14
05051986000794YelloPort530004S2017-07-10
05051986000831YelloPort550004S2017-07-10
05051986000824YelloPort550004R2016-09-23
05051986001050YelloPort585021S2016-09-23
05051986002286YelloPort Plus - Laparoscopic Port Access SystemYA03VSS012016-09-23
05051986002347YelloPort Plus - Laparoscopic Port Access SystemYA05VSS012016-09-23
05051986002361YelloPort Plus - Laparoscopic Port Access SystemYA05VSS022016-09-23
05051986002385YelloPort Plus - Laparoscopic Port Access SystemYA05VSS032016-09-23
05051986002408YelloPort Plus - Laparoscopic Port Access SystemYA510STSA2016-09-23

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