FDA.reportPublic FDA data

MonoBalloon DIL-XL

Primary DI
04048223078235
Brand
MonoBalloon DIL-XL
Company
Pajunk GmbH Medizintechnologie
Model
1284-60-11
Catalog number
1284-60-11
Device description
MonoBalloon DIL-XL Unilateral dilatation balloon Ø11mm round, Extra Large
Published
2025-03-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

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
K090631000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090631000PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMSPAJUNK GmbH Medizintechnologie2009-04-16GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048223057650PackageGS15In Commercial Distribution
04048223078235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048223057650040482230576504048223057650
04048223078235040482230782354048223078235

GMDN Terms#

Term, Definition table
TermDefinition
Surgical balloon dissectorA device used to dissect connective tissue layers creating access to a surgical site for a variety of surgical procedures. The device typically consists of a cannula, a distention balloon, an obturator, an inflation bulb, and a regulating valve(s). An endoscope is introduced into the cannula to monitor the dissection and/or the insertion process. The balloon is inflated to fill volume exerting pressure on the tissue layers. It is then deflated and removed, and distention is maintained by infusion of carbon dioxide (CO2) via the cannula. This device can be used for hernia repair, varicocele dissection, sympathectomy, lymph node biopsy, or perforator vein ligation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter11Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1 770-493-6832info@pajunk-usa.com

Regulatory Flags#

DUNS number
317654283
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048223122655Tuohy II1170-6I0911170-6I0912026-10-22
04048223122679Tuohy II1170-6K0811170-6K0812026-10-22
04048223122693Tuohy II1170-6K0911170-6K0912026-10-22
04048223122716Tuohy II1170-6K1201170-6K1202026-10-22
04048223122730Tuohy II1170-6M0811170-6M0812026-10-22
04048223122754Tuohy II1170-6M0911170-6M0912026-10-22
04048223122792Tuohy II1170-6O0811170-6O0812026-10-22
04048223122815Tuohy II1170-6O0911170-6O0912026-10-22
04048223122877Tuohy II NRFit1176-6I0911176-6I0912026-10-22
04048223122891Tuohy II NRFit1176-6K0811176-6K0812026-10-22
04048223122914Tuohy II NRFit1176-6K0911176-6K0912026-10-22
04048223122938Tuohy II NRFit1176-6K1201176-6K1202026-10-22
04048223122952Tuohy II NRFit1176-6M0811176-6M0812026-10-22
04048223122976Tuohy II NRFit1176-6M0911176-6M0912026-10-22
04048223122990Tuohy II NRFit1176-6M1201176-6M1202026-10-22
04048223123010Tuohy II NRFit1176-6O0811176-6O0812026-10-22
04048223123034Tuohy II NRFit1176-6O0911176-6O0912026-10-22
04048223124574Tuohy II NRFit1176-6K1031176-6K1032026-10-22
04048223124581Tuohy II NRFit1176-6M1031176-6M1032026-10-22
04048223124611Tuohy II1170-6M1201170-6M1202026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776436827MillenniumAvalign Technologies, Inc.GCJ2026-10-22
B382SD772553050Surgical DirectSurgical Direct, Inc.GCJ2026-10-22
00190776435677MillenniumAvalign Technologies, Inc.GCJ2026-10-21
00190776435684MillenniumAvalign Technologies, Inc.GCJ2026-10-21
00190776435493MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435547MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435295MillenniumAvalign Technologies, Inc.GCJ2026-10-19
00190776435455MillenniumAvalign Technologies, Inc.GCJ2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
04548736175013OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175068OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175112OLYMPUSSONY CORPORATIONGCJ2026-10-15
00190776434922MillenniumAvalign Technologies, Inc.GCJ2026-10-14
00190776434823MillenniumAvalign Technologies, Inc.GCJ2026-10-13
00190776434854MillenniumAvalign Technologies, Inc.GCJ2026-10-13
B382SD56300680Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
B382SD563006820Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
00190776434250MillenniumAvalign Technologies, Inc.GCJ2026-10-09
00848657078481AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00848657078498AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00190776433697MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433703MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433710MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433727MillenniumAvalign Technologies, Inc.GCJ2026-10-07