FDA.reportPublic FDA data

ESPINER TISSUE RETRIEVAL SYSTEM

Primary DI
05060358121715
Brand
ESPINER TISSUE RETRIEVAL SYSTEM
Company
ESPINER MEDICAL LIMITED
Model
EMP170ECO
Device description
Laparoscopic tissue retrieval sac for use with minimally invasive procedures.
Published
2016-09-23
Public version status
Update
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
K111845000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111845000THE ESPINER SAC OR E SACEspiner Medical Limited2011-09-26GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060358120862PackageGS110Not in Commercial Distribution
05060358120961PackageGS125Not in Commercial Distribution
5060358120145PackageGS15In Commercial Distribution
05060358121715PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060358120862050603581208625060358120862
05060358120961050603581209615060358120961
5060358120145050603581201455060358120145
05060358121715050603581217155060358121715

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1200Milliliter

Contacts#

Phone, Email table
PhoneEmail
1-508-3848490bbarrett@globalmedllc.com

Regulatory Flags#

DUNS number
774603880
Device count
1
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
05060358121579ESPINER TISSUE RETRIEVAL SYSTEMEMP200ECO-R-102023-05-15
05060358121609ESPINER TISSUE RETRIEVAL SYSTEMEMP50ECO-R2016-09-23
05060358121616ESPINER TISSUE RETRIEVAL SYSTEMEMP70ECO2016-09-23
05060358121623ESPINER TISSUE RETRIEVAL SYSTEMEMP70ECO-S2016-09-23
05060358121630ESPINER TISSUE RETRIEVAL SYSTEMEMP95ECO2016-09-23
05060358121647ESPINER TISSUE RETRIEVAL SYSTEMEMP100ECO2016-09-23
05060358121654ESPINER TISSUE RETRIEVAL SYSTEMEMP100ECO-S2016-09-23
05060358121661ESPINER TISSUE RETRIEVAL SYSTEMEMP110ECO-R2016-09-23
05060358121678ESPINER TISSUE RETRIEVAL SYSTEMEMP140ECO2016-09-23
05060358121685ESPINER TISSUE RETRIEVAL SYSTEMEMP140ECO-S2016-09-23
05060358121692ESPINER TISSUE RETRIEVAL SYSTEMEMP145ECO2016-09-23
05060358121708ESPINER TISSUE RETRIEVAL SYSTEMEMP160ECO-S2016-09-23
05060358121722ESPINER TISSUE RETRIEVAL SYSTEMEMP175ECO-W2016-09-23
05060358121739ESPINER TISSUE RETRIEVAL SYSTEMEMP180ECO2016-09-23
05060358121746ESPINER TISSUE RETRIEVAL SYSTEMEMP200ECO2016-09-23
05060358121753ESPINER TISSUE RETRIEVAL SYSTEMEMP230ECO2016-09-23
05060358121760ESPINER TISSUE RETRIEVAL SYSTEMEMP240ECO-S2016-09-23
05060358121777ESPINER TISSUE RETRIEVAL SYSTEMEMP600ECO2016-09-23
05060358121784ESPINER TISSUE RETRIEVAL SYSTEMECO60GREEN2016-09-23
05060358121791ESPINER TISSUE RETRIEVAL SYSTEMECO61GREEN2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04717480900343Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900350Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900367Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900398Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900404Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900763Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900770Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900787Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900800Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
E496C05HPDH0Handle for pneumodissection HookAB MEDICAGCJ2026-06-08
E496C05IDCH20ST1Hook insert and tube for pneumodissection D=5,0mm Lg=20cm, sterile single useAB MEDICAGCJ2026-06-08
E496C05IDCH33ST1Hook insert and tube for pneumodissection D=5,0mm Lg=33cm, sterile single useAB MEDICAGCJ2026-06-08
E496C35IDCH20ST1Hook insert and tube for pneumodissection D=3,5mm Lg=20cm, sterile single useAB MEDICAGCJ2026-06-08
E496C35IDCH33ST1Hook insert and tube for pneumodissection D=3,5mm Lg=33cm, sterile single useAB MEDICAGCJ2026-06-08
00198506091414ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-05
00198506091421ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-05
00198506091438ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-05
00198506091247ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-03
00198506091254ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-03
00192896123427TrocarSONTEC INSTRUMENTS, INC.GCJ2026-06-02
00192896123434Flexible Trocar SleeveSONTEC INSTRUMENTS, INC.GCJ2026-06-02
E496C35BTU200C35-Bipolar Tube L 20cm D 3,5mmAB MEDICAGCJ2026-05-28
E496C35IBDM200C35- Bipolar Maryland Insert L20cm D 3,5mmAB MEDICAGCJ2026-05-28
E496C35IBFS200C35-Bipolar Insert L 20cm D 3,5mmAB MEDICAGCJ2026-05-28