FDA.reportPublic FDA data

VERSITIP

Primary DI
03596010103291
Brand
VERSITIP
Company
Smith & Nephew, Inc.
Model
2141
Catalog number
2141
Device description
ACMI INSTRUMENT AI VERSITIP ADAPTOR FOR 4.0 MM AND 5.0 MM LIGHT GUIDES INTENDED TO INTERFACE SMITH and NEPHEW GEMINI UNIVERSAL FIBER OPTIC LIGHT CABLES WITH ACMI ENDOSCOPES
Published
2015-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K914919000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914919000SMITH & NEPHEW DYONICS LAPAROSCOPY SYSTEMSmith & Nephew Dyonics, Inc.1992-01-09GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010103291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010103291035960101032913596010103291

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic light source adaptorA device that provides an optical interface to match the light characteristics from an external light source (from a different endoscope manufacturer or model) to the fibreoptic bundles of an endoscope. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-5700gudid@smith-nephew.com
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00885556834237Silicone Toe SystemCGT-205TCGT-205T2022-12-22
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00885556835029Ti6 Internal Fixation SystemDS1007DS10072022-12-22
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00885556838785Total Foot System 2282302728230272022-12-21
00885556841631XT Revision Ankle Replacement SystemMJU984TMJU984T2022-12-21
00885556841778XT Revision Ankle Replacement SystemMJV222TMJV222T2022-12-21
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Primary DI, Brand, Company table
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