NA

Primary DI
03700569609474
Brand
NA
Company
NEWCLIP TECHNICS
Model
RTDQ1
Catalog number
RTDQ1
Published
2016-09-28
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
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143061000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143061000Activ Ankle Locking Plating SystemNewclip Technics2015-01-26HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700569609474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700569609474037005696094743700569609474

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, non-sterileA non-sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion). This device is intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
263281904
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
00370056966354NARDT2.8L38D-STRDT2.8L38D-ST2026-07-28
03700569628253NACT3.5L20D-STCT3.5L20D-ST2026-07-28
03700569628277NACT3.5L22D-STCT3.5L22D-ST2026-07-28
03700569641269NAH1.3GLT4.0L70DH1.3GLT4.0L70D2026-07-28
03700569644451NASOT3.5L10DSOT3.5L10D2026-07-28
03700569644468NASOT3.5L12DSOT3.5L12D2026-07-28
03700569644475NASOT3.5L14DSOT3.5L14D2026-07-28
03700569644482NASOT3.5L16DSOT3.5L16D2026-07-28
03700569644499NASOT3.5L18DSOT3.5L18D2026-07-28
03700569644505NASOT3.5L20DSOT3.5L20D2026-07-28
03700569644512NASOT3.5L22DSOT3.5L22D2026-07-28
03700569644529NASOT3.5L24DSOT3.5L24D2026-07-28
03700569644581NACT3.5L20DCT3.5L20D2026-07-28
03700569644598NACT3.5L22DCT3.5L22D2026-07-28
03700569644611NACT3.5L26DCT3.5L26D2026-07-28
03700569652555NACT3.5L32DCT3.5L32D2026-07-28
03700569654757NACT3.5L40DCT3.5L40D2026-07-28
03700569657727NACT2.8L16DCT2.8L16D2026-07-28
03700569657963NACT2.8L40DCT2.8L40D2026-07-28
03700569659219Alians Elbow SNTGY1DNTGY1D2026-07-28

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