FDA.reportPublic FDA data

Spring Grip

Primary DI
20884521099415
Brand
Spring Grip
Company
Covidien LP
Model
174103
Device description
Anchoring Device
Published
2016-09-24
Public version status
Update
Distribution status
Not 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
FBQTrocar, gastro-urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBQTrocar, Gastro-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K900123000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K900123000AUTO SUTURE SURGIPORT SPIRAL SLEEVEUnited States Surgical, A Division of Tyco Healthc1990-04-04FBQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521099418PackageGS112Not in Commercial Distribution
20884521099415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452109941810884521099418
2088452109941520884521099415

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula anchor, single-useA small, sterile, luminal device designed to enable a laparoscopic access cannula (port) to be secured to the skin/tissue of an incision site during a laparoscopic surgical procedure. The outer surface is typically textured/ribbed and intended to grip the tissue whilst the laparoscopic access cannula is inserted through the device lumen and fixed at the required insertion depth using a clamping/locking mechanism. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit130 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521197701superDimensionSDC102016-09-24
10884521198777superDimensionSDC202016-09-24
10884521198784superDimensionSDC52016-09-24
10884521198791superDimensionSDM22016-09-24
10884521198807superDimensionSDM32016-09-24
10884521539709SuperLockSDGN4472016-09-24
10884521757868Maxon8886621943-22020-01-29
10884521762688SuperLockSDGN4472021-07-05
10884521837102ILLUMISITEILS-1000-CS2024-08-09
10884521837126ILLUMISITEILS-1000-CS2024-08-09
10884521837133ILLUMISITEILS-1000-CS2024-08-09
10884521837140ILLUMISITEILS-1000-CS2024-08-09
10884521837157ILLUMISITEILS-1000-CS2024-08-09
10884521842915ILLUMISITEILS-1000-CS2024-08-09
10884521837096ILLUMISITEILS-1000-CS2023-09-17
10884521199996superDimensionAAS00161-20RAAS00161-20R2016-09-24
10884521747425superDimensionPMB00667-012018-02-28
10884521747432superDimensionPMB00569-012018-02-28
10884521199989superDimensionAAS00161-202016-09-24
10884521747418superDimensionILS-0001-FN2018-02-28

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Primary DI, Brand, Company table
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00849233014015Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-09-29
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00849233013162Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-05-01
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10849233013121Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-04-23
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08964003163853Doctor NiceB. Ali ImpexFBQ2024-01-29
08964003163860Doctor NiceB. Ali ImpexFBQ2024-01-29
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08964003163891Doctor NiceB. Ali ImpexFBQ2024-01-29
00849233011144Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-11-20
00849233011175Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-11-16