FDA.reportPublic FDA data

ESPINER TISSUE RETRIEVAL SYSTEM

Primary DI
05060358121647
Brand
ESPINER TISSUE RETRIEVAL SYSTEM
Company
ESPINER MEDICAL LIMITED
Model
EMP100ECO
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
05060358120848PackageGS120Not in Commercial Distribution
05060358120947PackageGS150Not in Commercial Distribution
5060358120046PackageGS110In Commercial Distribution
05060358121647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060358120848050603581208485060358120848
05060358120947050603581209475060358120947
5060358120046050603581200465060358120046
05060358121647050603581216475060358121647

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 Volume200Milliliter

Contacts#

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

Regulatory Flags#

DUNS number
774603880
Device count
1
DM exempt
true
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
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
05060358121715ESPINER TISSUE RETRIEVAL SYSTEMEMP170ECO2016-09-23
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
00190776427931MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428051MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428303MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776427429MillenniumAvalign Technologies, Inc.GCJ2026-08-26
04580826928451PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928543PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928581PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928604PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
08800035701499CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701505CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701512CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701529CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701536CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701543CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701949CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701956CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701963CORE-TrocarINCORE CO., LTDGCJ2026-08-25
B382SD13448970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD16008970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD161730Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205052000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205082000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD7720508TS2000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205252000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
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