FDA.reportPublic FDA data

Alians Forearm

Primary DI
03700569602932
Brand
Alians Forearm
Company
NEWCLIP TECHNICS
Model
ETSIS2
Catalog number
ETSIS2
Published
2024-11-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
K170843000
K262649000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170843000Alians Fragment SpecificNewclip Technics2017-06-16HRS
K262649000Alians ForearmNewclip Technics2026-09-28HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700569602932PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700569602932037005696029323700569602932

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
263281904
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700569653873NACT2.8L10DCT2.8L10D2026-11-05
03700569658274NAH1.25QT3.5L44DH1.25QT3.5L44D2026-11-05
03700569658281NAH1.25QT3.5L44D-STH1.25QT3.5L44D-ST2026-11-05
03700569667931NAH1.25QT3.5L14DH1.25QT3.5L14D2026-11-05
03700569667948NAH1.25QT3.5L14D-STH1.25QT3.5L14D-ST2026-11-05
03700569667955NAH1.25QT3.5L16DH1.25QT3.5L16D2026-11-05
03700569667962NAH1.25QT3.5L16D-STH1.25QT3.5L16D-ST2026-11-05
03700569667979NAH1.25QT3.5L18DH1.25QT3.5L18D2026-11-05
03700569667986NAH1.25QT3.5L18D-STH1.25QT3.5L18D-ST2026-11-05
03700569667993NAH1.25QT3.5L20DH1.25QT3.5L20D2026-11-05
03700569668006NAH1.25QT3.5L20D-STH1.25QT3.5L20D-ST2026-11-05
03700569668013NAH1.25QT3.5L22DH1.25QT3.5L22D2026-11-05
03700569668020NAH1.25QT3.5L22D-STH1.25QT3.5L22D-ST2026-11-05
03700569668037NAH1.25QT3.5L24DH1.25QT3.5L24D2026-11-05
03700569668044NAH1.25QT3.5L24D-STH1.25QT3.5L24D-ST2026-11-05
03700569668051NAH1.25QT3.5L26DH1.25QT3.5L26D2026-11-05
03700569668068NAH1.25QT3.5L26D-STH1.25QT3.5L26D-ST2026-11-05
03700569668075NAH1.25QT3.5L28DH1.25QT3.5L28D2026-11-05
03700569668082NAH1.25QT3.5L28D-STH1.25QT3.5L28D-ST2026-11-05
03700569668099NAH1.25QT3.5L30DH1.25QT3.5L30D2026-11-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810112592467TriLEAPSynthes GmbHHRS2024-02-23
00810112592474TriLEAPSynthes GmbHHRS2024-02-23
00810112592634TriLEAPSynthes GmbHHRS2024-02-23
00810112592832TriLEAPSynthes GmbHHRS2024-02-23
00810112592849TriLEAPSynthes GmbHHRS2024-02-23
00810112592986TriLEAPSynthes GmbHHRS2024-02-22
00810112592993TriLEAPSynthes GmbHHRS2024-02-22
00810112593006TriLEAPSynthes GmbHHRS2024-02-22
00810112593013TriLEAPSynthes GmbHHRS2024-02-22
00810112593020TriLEAPSynthes GmbHHRS2024-02-22
00810112593037TriLEAPSynthes GmbHHRS2024-02-22
00810112593044TriLEAPSynthes GmbHHRS2024-02-22
00810112593051TriLEAPSynthes GmbHHRS2024-02-22
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00810112593075TriLEAPSynthes GmbHHRS2024-02-22
00810112593082TriLEAPSynthes GmbHHRS2024-02-22
00810112593099TriLEAPSynthes GmbHHRS2024-02-22
00810112593105TriLEAPSynthes GmbHHRS2024-02-22
00810112593112TriLEAPSynthes GmbHHRS2024-02-22
00810112593129TriLEAPSynthes GmbHHRS2024-02-22
00810112593136TriLEAPSynthes GmbHHRS2024-02-22
00810112593143TriLEAPSynthes GmbHHRS2024-02-22
00810112593150TriLEAPSynthes GmbHHRS2024-02-22
00810112593167TriLEAPSynthes GmbHHRS2024-02-22
00810112593174TriLEAPSynthes GmbHHRS2024-02-22
00810112593181TriLEAPSynthes GmbHHRS2024-02-22