FDA.reportPublic FDA data

SUPERBAG

Primary DI
00850013527601
Brand
SUPERBAG
Company
Dannik LLC
Model
NI0140
Catalog number
PNI0140
Device description
PMI SuperBag 5 Small Specimen Retrieval System, 140mL
Published
2023-01-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
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
10850013527608PrimaryGS10
00850013527601Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001352760810850013527608
00850013527601008500135276018500135276010850013527601

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117407001
Device count
10
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
10850013527790SOLOBAGPPI0280PPI02802025-06-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD1184590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD12711090Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD1271390Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD1271590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13018770Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13168350Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD23373490Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD770561050Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD775011530Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD775021630Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD77505650Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD7751586C0Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD7751587C0Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
00850045863012ArthroFree® 2 ReceiverLazurite Holdings LLCGCJ2026-07-10
00850045863029ArthroFree® 2 Wireless Camera HeadLazurite Holdings LLCGCJ2026-07-10
00850045863036ArthroFree® 2 Operating Room KitLazurite Holdings LLCGCJ2026-07-10
00850045863043ArthroFree® 2 Single Camera Head SetLazurite Holdings LLCGCJ2026-07-10
B382SD883110450Surgical DirectSurgical Direct, Inc.GCJ2026-07-10
B382SD88324450Surgical DirectSurgical Direct, Inc.GCJ2026-07-10
00190776421731MillenniumAvalign Technologies, Inc.GCJ2026-06-24
00190776421663MillenniumAvalign Technologies, Inc.GCJ2026-06-23
00190776421687MillenniumAvalign Technologies, Inc.GCJ2026-06-23
00198506091506ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-10
00198506044366ELMEDELMED INCORPORATEDGCJ2026-06-09
00812231033906PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033913PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033920PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231034095PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231034101PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
04717480900336Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08