FDA.reportPublic FDA data

UNiD OCT

Primary DI
03613720269397
Brand
UNiD OCT
Company
MEDICREA INTERNATIONAL
Model
B33223500-01
Catalog number
B33223500-01
Device description
UNiD CoCr Rod Ø3.5mm 1-3 LV
Published
2017-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NKGOrthosis, Cervical Pedicle Screw Spinal Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153169000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153169000PASS OCT Patient Specific RodsMedicrea International2016-01-29NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03613720269397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03613720269397036137202693973613720269397

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
383228632
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03613720249832PASS TLA220302002017-01-31
03613720286875UNiD OCTB33243600-01B33243600-012021-08-19
03613720286882UNiD OCTB33243500-01B33243500-012021-08-19
03613720286899UNiD OCTB33143600-01B33143600-012021-08-19
03613720286905UNiD OCTB33143500-01B33143500-012021-08-19
03613720286936UNiD RODB33136012-01B33136012-012021-08-19
03613720286943UNiD RODB33236012-01B33236012-012021-08-19
03613720268451UNiD RODB33125512-01B33125512-012017-06-12
03613720268468UNiD RODB33125512-02B33125512-022017-06-12
03613720268628UNiD RODB33225512-01B33225512-012017-06-12
03613720268635UNiD RODB33225512-02B33225512-022017-06-12
03613720268963UNiD RODB33126012-01B33126012-012017-08-28
03613720268970UNiD RODB33126012-02B33126012-022017-08-28
03613720269137UNiD RODB33226012-01B33226012-012017-08-28
03613720269144UNiD RODB33226012-02B33226012-022017-08-28
03613720269304UNiD OCTB33123500-01B33123500-012017-09-12
03613720269311UNiD OCTB33123500-02B33123500-022017-09-12
03613720269403UNiD OCTB33223500-02B33223500-022017-09-12
03613720286585UNiD MISB33155522-01B33155522-012021-02-24
03613720286592UNiD MISB33155522-02B33155522-022021-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800322693902VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322693919VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322693926VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322693933VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322693940VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322693957VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322693964VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322693971VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322693988VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322693995VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694008VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694015VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694022VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694039VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694046VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694053VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694060VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694077VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694084VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694091VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694107VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694114VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694121VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694138VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694145VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694152VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694169VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694176VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694183VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03
08800322694190VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-11-03