FDA.reportPublic FDA data

NO BRAND

Primary DI
00885556631720
Brand
NO BRAND
Company
Smith & Nephew, Inc.
Model
71158072
Catalog number
71158072
Device description
DEPTH GAUGE FOR 1.8MM PEGS AND 2.4MM SCREWS
Published
2016-12-01
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
HRSPlate, fixation, bone
HWCScrew, fixation, bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161665000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161665000VLP Wrist Fracture SystemSmith & Nephew, Inc.2016-11-15HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556631720PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556631720008855566317208855566317200885556631720

GMDN Terms#

Term, Definition table
TermDefinition
Surgical depth gauge, reusableA surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010482280CLEAR-TRAC721012172101212015-10-22
03596010532619NA721071972107192015-08-30
03596010505132SCULPTOR721069772106972015-08-30
03596010505149SCULPTOR721069672106962015-08-30
03596010505170SCULPTOR721069572106952015-08-30
03596010505194SCULPTOR721070072107002015-08-30
00885554016703560P72202351722023512015-08-29
00885556919781Real IntelligenceROB30007ROB300072026-10-13
00885556924327Real IntelligenceROB30801ROB308012026-10-08
03596010445803NA720903072090302015-08-30
03596010470294SAPHYRE720968472096842015-08-30
03596010470331ABLATOR720965972096592015-08-30
03596010470348ABLATOR720965872096582015-08-30
03596010470416ABLATOR720965172096512015-08-30
03596010470577ABLATOR720965072096502015-08-30
03596010470614TAC-S720963272096322015-08-30
03596010448446TWINFIX720910972091092015-08-30
03596010470393ABLATOR720965372096532015-08-30
03596010470423ABLATOR720964972096492015-08-30
03596010510976NA721004072100402015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810112592245TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592252TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592252TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592429TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592429TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592450TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592450TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592474TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592474TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592634TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592634TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592832TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592832TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592849TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592849TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592986TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112592986TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112592993TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112592993TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593006TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593006TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593013TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593013TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593020TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593020TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593037TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593037TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593044TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593044TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22