FDA.reportPublic FDA data

DANNIK

Primary DI
10850013527936
Brand
DANNIK
Company
Dannik LLC
Model
NI0185
Catalog number
NI0185
Device description
7mm Specimen Retrieval System, 185 mL
Published
2026-08-17
Public version status
New
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
10850013527936PrimaryGS10
00850013527939Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001352793610850013527936
00850013527939008500135279398500135279390850013527939

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
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
108500135279817mm XL SUPERBAGPNI0185RXLPNI0185RXL2026-08-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776425883MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425906MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425968MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425975MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426361MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426378MillenniumAvalign Technologies, Inc.GCJ2026-08-18
108500135279817mm XL SUPERBAGDannik LLCGCJ2026-08-17
00889095731972ALVUEGLOBUS MEDICAL, INC.GCJ2026-08-14
00889095731989ALVUEGLOBUS MEDICAL, INC.GCJ2026-08-14
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