FDA.reportPublic FDA data

Panniculus Retraction Kit

Primary DI
00814247021304
Brand
Panniculus Retraction Kit
Company
CLINICAL INNOVATIONS, LLC
Model
PRS-CK-05SM
Device description
This is a Kit which contains one traxi device and a small Abby device. These devices are designed to retract excess panniculus tissue intraoperatively (traxi) and postoperatively (ABBy). The Kit offers a full solution for panniculus retraction from surgery to the first two weeks of recovery. Individual records are available for both devices within the GUDID database.
Published
2026-05-31
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

Product Codes#

Code, Name table
CodeName
CCXSupport, Patient Position
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814247021304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814247021304008142470213048142470213040814247021304

GMDN Terms#

Term, Definition table
TermDefinition
Panniculus skin-adhesive retractorA noninvasive adhesive band/tape intended to be adhered to the skin to retract panniculus abdominal tissue during surgery, to facilitate access to the operative site by the surgeon. It is typically used on bariatric patients or patients with redundant tissue during Caesarean section delivery or abdominal surgery. This is a single-use device.

Regulatory Flags#

DUNS number
809524291
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallPRS-CK-05MD2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargePRS-CK-05LG2026-05-31
00814247020345traxi® Panniculus RetractorPRS-10302016-09-01
00814247020369traxi® Panniculus Retractor ExtenderPRS-10502016-09-01
30814247020346traxi® Panniculus Retractorhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetaiPRS-05302016-09-01
30814247020360traxi® Panniculus Retractor ExtenderPRS-05502016-09-01
00814247020802traxi® Panniculus RetractorPRS-EVAL2016-09-22
00814247021243Kiwi® OmniCup®VAC-DUAL MT2025-12-16
00814247020178Koala®IPC-5000E2016-09-01
00814247020741Goldtrace OneCNS0000082016-09-01
00814247020505Spiral Fetal Scalp ElectrodeCNS0000042016-09-01
00814247020512FSE CablesSBT-70102016-09-01
00814247020529FSE CablesSBT-70112016-09-01
00814247020536FSE CablesSBT-70122016-09-01
00814247020543FSE CablesSBT-70142016-09-01
00814247020550FSE CablesSBT-70152016-09-01
00814247020567FSE CablesSBT-70162016-09-01
00814247020574FSE CablesSBT-70172016-09-01
00814247020581FSE CablesSBT-70182016-09-01
00814247020598FSE CablesSBT-70192016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallCLINICAL INNOVATIONS, LLCCCX2026-05-31
00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallCLINICAL INNOVATIONS, LLCKGX2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCKGX2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCCCX2026-05-31
00850087488389CeeportCEEPORT INC.KGX2026-05-29
00850087488426CeeportCEEPORT INC.KGX2026-05-29
00050428142516CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-05-28
10080196413737MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-04-27
09420012436047Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
09420012436061Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
10080196413256MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
10080196413485MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
10080196413690MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
10080196669523MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669530MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669547MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
07613327632859SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327632866SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
G242SB03RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB07SDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB12RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SS03DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB01RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SB05SDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SB10RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS01DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS04DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS05DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05