FDA.reportPublic FDA data

Procedure Pack

Primary DI
07640167750771
Brand
Procedure Pack
Company
SIE AG, Surgical Instrument Engineering
Model
9.5/140
Catalog number
510.701.134
Device description
Procedure Pack Ø 9.5mm, 140µm flap thickness
Published
2018-09-14
Public version status
Update
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
HQFLaser, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQFLaser, OphthalmicOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053511000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053511000DA VINCI FEMTOSECOND SURGICAL LASERSie Ltd Surgical Instrument Engineering2006-03-10GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640167750771PackageGS110In Commercial Distribution
07640167750238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640167750771076401677507717640167750771
07640167750238076401677502387640167750238

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical procedure kit, non-medicated, single-useA collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter9.5Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8667084490usa@ziemergroup.com

Regulatory Flags#

DUNS number
482163628
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
07640167750023FEMTO LDVZ6510.003.0062016-09-15
07640167750030FEMTO LDVZ4510.003.0042016-09-15
07640167750047FEMTO LDVZ2510.003.0022016-09-15
07640167750573FEMTOZ8 NEO510.003.0092022-06-10
07640167751334Procedure Pack Z8Cataract L2510.700.1192020-12-22
07640167751341Procedure Pack Z88.5 CS Z8 S510.700.1202020-12-22
07640167751358Procedure Pack Z89.0 CS Z8 S510.700.1212020-12-22
07640167751365Procedure Pack Z89.5 CS Z8 S510.700.1222020-12-22
07640167751372Procedure Pack Z810.0 CS Z8 S510.700.1232020-12-22
07640167751389Procedure Pack Z8L2510.700.1242020-12-22
07640167750092Procedure Pack10/100510.701.1402018-09-14
07640167750108Procedure Pack10/110510.701.1412018-09-14
07640167750115Procedure Pack10/140510.701.1442018-09-14
07640167750122Procedure Pack10/90510.701.1492018-09-14
07640167750139Procedure Pack8.5/100510.701.1102018-09-14
07640167750146Procedure Pack8.5/110510.701.1112018-09-14
07640167750153Procedure Pack8.5/140510.701.1142018-09-14
07640167750160Procedure Pack8.5/90510.701.1192018-09-14
07640167750177Procedure Pack9.0/100510.701.1202018-09-14
07640167750184Procedure Pack9.0/110510.701.1212018-09-14

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