FDA.reportPublic FDA data

Snaploc

Primary DI
10827002596860
Brand
Snaploc
Company
COOK INCORPORATED
Model
G59686
Catalog number
SNAPLOC-P
Device description
Snaploc wire guide locking device
Published
2022-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ODCEndoscope channel accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODCEndoscope Channel AccessoryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213483000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213483000SnapLoc Wire LockWilson Cook Medical2022-04-26ODC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002596860PackageGS110In Commercial Distribution
00827002596863PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082700259686010827002596860
00827002596863008270025968638270025968630827002596863

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic guidewire holderA device intended to be used during diagnostic and/or therapeutic endoscopy of the gastrointestinal (GI) tract [e.g., endoscopic retrograde cholangiopancreatography (ERCP)] to hold a guidewire in place at a given insertion depth through the working channel of an endoscope. It is typically a small plastic device intended to be attached to the proximal end of the endoscope, with a feature to hold the guidewire in place (e.g., j-slot). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
079720472
Device count
1
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002606616OpTUS Ultra PleuralG60661OPTUS-SET-5.5-15-PIGTAIL2026-10-22
00827002606623OpTUS Ultra PleuralG60662OPTUS-TRAY-5.5-15-PIGTAIL2026-10-22
00827002606630OpTUS Ultra PleuralG60663OPTUS-SET-8.5-20-PIGTAIL2026-10-22
00827002606647OpTUS Ultra PleuralG60664OPTUS-TRAY-8.5-20-PIGTAIL2026-10-22
00827002606654OpTUS Ultra PleuralG60665OPTUS-SET-10-20-PIGTAIL2026-10-22
00827002606661OpTUS Ultra PleuralG60666OPTUS-TRAY-10-20-PIGTAIL2026-10-22
00827002606678OpTUS Ultra PleuralG60667OPTUS-SET-12-30-STRAIGHT2026-10-22
00827002606685OpTUS Ultra PleuralG60668OPTUS-TRAY-12-30-STRAIGHT2026-10-22
00827002606692OpTUS Ultra PleuralG60669OPTUS-SET-12-30-PIGTAIL2026-10-22
00827002606708OpTUS Ultra PleuralG60670OPTUS-TRAY-12-30-PIGTAIL2026-10-22
00827002606715OpTUS Ultra PleuralG60671OPTUS-SET-14-30-STRAIGHT2026-10-22
00827002606722OpTUS Ultra PleuralG60672OPTUS-TRAY-14-30-STRAIGHT2026-10-22
00827002606739OpTUS Ultra PleuralG60673OPTUS-SET-14-30-PIGTAIL2026-10-22
00827002606746OpTUS Ultra PleuralG60674OPTUS-TRAY-14-30-PIGTAIL2026-10-22
00827002606753OpTUS Ultra PleuralG60675OPTUS-SET-16-30-STRAIGHT2026-10-22
00827002606760OpTUS Ultra PleuralG60676OPTUS-TRAY-16-30-STRAIGHT2026-10-22
00827002606777OpTUS Ultra PleuralG60677OPTUS-SET-16-30-PIGTAIL2026-10-22
00827002606784OpTUS Ultra PleuralG60678OPTUS-TRAY-16-30-PIGTAIL2026-10-22
00827002606791OpTUS Ultra PleuralG60679OPTUS-SET-20-30-STRAIGHT2026-10-22
00827002606807OpTUS Ultra PleuralG60680OPTUS-TRAY-20-30-STRAIGHT2026-10-22

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Primary DI, Brand, Company table
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