FDA.reportPublic FDA data

LaproSac

Primary DI
10850067560149
Brand
LaproSac
Company
Surgical Principals, Inc
Model
EMP600-SPI-5
Device description
LaproSac™ 6000 ML Rip-Stop Nylon, 5 Per Box
Published
2026-01-09
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

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
K251743000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251743000SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval SystemSurgical Principals, Inc.2025-09-22GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850067560149PrimaryGS10
00850067560142Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085006756014910850067560149
00850067560142008500675601428500675601420850067560142

GMDN Terms#

Term, Definition table
TermDefinition
Tissue extraction bagAn impervious, flexible, sterile container intended to be used during minimally-invasive, typically keyhole, surgical techniques (e.g., laparoscopic) to extract dissected patient body tissue. The device is inserted into the body through a large bore cannula port, and the tissue to be extracted is placed in the bag with trans-cannula instruments and evacuated through the cannula. The device typically includes an x-ray detectable thread. This device may be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, or gallbladder removal. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
253-441-6509customerservice@surgicalprincipals.com

Regulatory Flags#

DUNS number
782873892
Device count
5
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
10850067560316LaproSacEMP300-RGD-3EMP300-RGD-32026-05-22
10850067560231LaproSacEMP50-RGD-6EMP50-RGD-62026-04-10
10850067560156LaproSacEMP100-RGD-62026-01-12
10850067560163LaproSacEMP200-RGD-6EMP200-RGD-62026-01-12
10850067560248LaproSacEMP80-RGD-6EMP80-RGD-62026-01-12
10850067560132LaproSacEMP400-SPI-62026-01-09
00850067560135LaproSacEMP400-SPI-62026-01-09
00850067560142LaproSacEMP600-SPI-52026-01-09
10850067560170LaproCloseLCLOSE-100LCLOSE-1002025-12-11
10850067560187LaproCloseLCLOSE-200LCLOSE-2002025-12-11
10850067560194LaproCloseLCLOSE-300LCLOSE-3002025-12-11
10850067560224LaproClearLCLEAR-400LCLEAR-4002025-12-11
00850067560173LaproCloseLCLOSE-100LCLOSE-1002025-12-11
00850067560180LaproCloseLCLOSE-200LCLOSE-2002025-12-11
00850067560197LaproCloseLCLOSE-300LCLOSE-3002025-12-11
00850067560227LaproClearLCLEAR-400LCLEAR-4002025-12-11
10850067560002MaxRetract3316-8-SPI2025-10-23
10850067560019MaxRetract3316-1-SPI2025-10-23
10850067560026MaxRetract3350-8-SPI2025-10-23
10850067560033MaxRetract3350-1-SPI2025-10-23

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
10850013527936DANNIKDannik LLCGCJ2026-08-17
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