FDA.reportPublic FDA data

SOLOBAG

Primary DI
10850013527790
Brand
SOLOBAG
Company
Dannik LLC
Model
PPI0280
Catalog number
PPI0280
Device description
PMI SOLOBAG 10mm Poly Specimen Retrieval System, 280mL
Published
2025-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850013527790PrimaryGS10
00850013527793Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001352779010850013527790
00850013527793008500135277938500135277930850013527793

GMDN Terms#

Term, Definition table
TermDefinition
Tissue extraction bag introducerA sterile, hand-held, manual surgical instrument designed to introduce a folded tissue extraction bag into the patient's body through an appropriate access port during an endoscopic procedure. It is typically designed with a high-grade stainless steel stiff rod at the distal end around which the tissue extraction bag is folded and held in position with a gripping mechanism, e.g., prongs, and a handle at the proximal end. Once the bag is inside the body cavity, it is released and the introducer removed. This is a reusable device.

Regulatory Flags#

DUNS number
117407001
Device count
10
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850013527929True5mm™ SUPERBAG PNI0120PNI01202026-03-25
10850013527974EXTENDNI0100NI01002026-03-25
10850013527035DannikDMP5910F2023-01-21
10850013527042DannikDMP59202023-01-21
10850013527059DannikDMP59452023-01-21
10850013527066DannikDMP59502023-01-21
10850013527349DannikDMP59252023-01-21
10850013527356DannikDMP59052023-01-21
10850013527394PMI LAPSYSTEM™LSDLS-33MMETZLSDLS-33MMETZ2024-10-23
10850013527417PMI LAPSYSTEM™LSDLS-33MYLDLSDLS-33MYLD2024-10-23
10850013527448PMI LAPSYSTEM™LSDLS-33BBCKLSDLS-33BBCK2024-10-23
10850013527783PMI LAPSYSTEM™LSDLS-33CVMETZLSDLS-33CVMETZ2024-05-30
10850013527806PMI LAPSYSTEM™LSDLS-33GRASPERLSDLS-33GRASPER2024-10-23
10850013527950DANNIKPI0280PI02802025-06-27
00850013527793SOLOBAGPPI0280PPI02802025-06-27
00850013527953DANNIKPI0280PI02802025-06-27
00850013527397PMI LAPSYSTEM™LSDLS-33MMETZLSDLS-33MMETZ2024-10-23
00850013527410PMI LAPSYSTEM™LSDLS-33MYLDLSDLS-33MYLD2024-10-23
00850013527441PMI LAPSYSTEM™LSDLS-33BBCKLSDLS-33BBCK2024-10-23
00850013527809PMI LAPSYSTEM™LSDLS-33GRASPERLSDLS-33GRASPER2024-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776423605MillenniumAvalign Technologies, Inc.GCJ2026-08-07
00190776423650MillenniumAvalign Technologies, Inc.GCJ2026-08-07
00190776423667MillenniumAvalign Technologies, Inc.GCJ2026-08-07
00190776424510MillenniumAvalign Technologies, Inc.GCJ2026-08-07
00190776422745MillenniumAvalign Technologies, Inc.GCJ2026-08-03
00190776422752MillenniumAvalign Technologies, Inc.GCJ2026-08-03
04026704934812TELEFLEXTELEFLEX INCORPORATEDGCJ2026-08-03
B382SD4131490Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD4162910Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD49245120Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD55670280Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56325330Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56400150Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56534210Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD567910130Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56914330Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
00190776421960MillenniumAvalign Technologies, Inc.GCJ2026-07-31
00190776422325MillenniumAvalign Technologies, Inc.GCJ2026-07-31
00888867498105Arthrex®ARTHREX, INC.GCJ2026-07-31
14026704921741TELEFLEXTELEFLEX INCORPORATEDGCJ2026-07-31
B382SD13768130Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD13798130Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD14678780Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD15378970Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD15458990Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD161090Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD169920Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD30109760Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
00198506092183ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506092640ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29