FDA.reportPublic FDA data

TC-100

Primary DI
03596010489654
Brand
TC-100
Company
Smith & Nephew, Inc.
Model
3571143107
Catalog number
3571143107
Device description
7.0MM O.D. WASHER SST
Published
2015-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K993106000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993106000SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES)Smith & Nephew, Inc.1999-12-09HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
23596010489658PackageGS110In Commercial Distribution
03596010489654PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2359601048965823596010489658
03596010489654035960104896543596010489654

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone washer, sterileA sterile flat thin ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
045483575
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556925089NA74034445740344452026-07-14
00885556925379CORIOGRAPHROB20032ROB200322026-07-08
00885556925386CORIOGRAPHROB20031ROB200312026-07-08
00885556904879EVOS70887105708871052026-06-25
00885556904923EVOS70897130708971302026-06-25
00885556906163EVOS70879090708790902026-06-25
00885556906170EVOS70879095708790952026-06-25
00885556906187EVOS70879100708791002026-06-25
00885556906194EVOS70879105708791052026-06-25
00885556906200EVOS70879110708791102026-06-25
00885556906217EVOS70879115708791152026-06-25
00885556906224EVOS70879120708791202026-06-25
00885556906231EVOS70879125708791252026-06-25
00885556906248EVOS70879130708791302026-06-25
00885556906255EVOS70879135708791352026-06-25
00885556906262EVOS70879140708791402026-06-25
00885556906279EVOS70879145708791452026-06-25
00885556906286EVOS70879150708791502026-06-25
00885556906293EVOS70879155708791552026-06-25
00885556906309EVOS70879160708791602026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00190446944348Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952213Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952220Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952237Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952244Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952251Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952268Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952275Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952282Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952299Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952305Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952312Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952329Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446950110Arsenal FootTrilliant Surgical, LLCHRS2026-06-24
00190446950172Arsenal FootTrilliant Surgical, LLCHRS2026-06-24
00190446950189Arsenal FootTrilliant Surgical, LLCHRS2026-06-24
00190446950196Arsenal FootTrilliant Surgical, LLCHRS2026-06-24
00190446950202Arsenal FootTrilliant Surgical, LLCHRS2026-06-24
00190446950219Arsenal FootTrilliant Surgical, LLCHRS2026-06-24
00190446951964Arsenal FootTrilliant Surgical, LLCHRS2026-06-24
00190446951971Arsenal FootTrilliant Surgical, LLCHRS2026-06-24
00190446951988Arsenal FootTrilliant Surgical, LLCHRS2026-06-24
00190446951995Arsenal FootTrilliant Surgical, LLCHRS2026-06-24
00190446952015Arsenal FootTrilliant Surgical, LLCHRS2026-06-24
00190446952022Arsenal FootTrilliant Surgical, LLCHRS2026-06-24
00190446952039Arsenal FootTrilliant Surgical, LLCHRS2026-06-24
00190446952046Arsenal FootTrilliant Surgical, LLCHRS2026-06-24
00190446952060Arsenal FootTrilliant Surgical, LLCHRS2026-06-24
00190446952336Arsenal FootTrilliant Surgical, LLCHRS2026-06-24