FDA.reportPublic FDA data

NA

Primary DI
03596010566225
Brand
NA
Company
Smith & Nephew, Inc.
Model
72200841
Catalog number
72200841
Device description
CL FIXATION DEVICE 35MM
Published
2015-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GATSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010566225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010566225035960105662253596010566225

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, sterileA 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).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-5700gudid@smith-nephew.com
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
109903521
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556919712Real IntelligenceROB30001ROB300012026-03-10
00885556919729Real IntelligenceROB30002ROB300022026-03-10
00885556919743Real IntelligenceROB30003ROB300032026-03-10
00885556919750Real IntelligenceROB30004ROB300042026-03-10
00885556919767Real IntelligenceROB30005ROB300052026-03-10
00885556919774Real IntelligenceROB30006ROB300062026-03-10
00885556924198Real IntelligenceROB30026ROB300262026-03-10
00885556924204Real IntelligenceROB30021ROB300212026-03-10
00885556924211Real IntelligenceROB30027ROB300272026-03-10
00885556924228Real IntelligenceROB30022ROB300222026-03-10
00885556924235Real IntelligenceROB30023ROB300232026-03-10
00885556924242Real IntelligenceROB30024ROB300242026-03-10
00885556924266Real IntelligenceROB30028ROB300282026-03-10
00885556924273Real IntelligenceROB30020ROB300202026-03-10
00885556924297Real IntelligenceROB30880ROB308802026-03-10
20885556924307NAROB30031ROB300312026-03-10
00885556787786NA74034136740341362026-02-20
00885556884027NA74038834740388342026-02-20
00885556884034NA74038835740388352026-02-20
00885556884140NA74038846740388462026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20612479283385McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479283392McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479283408McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479283415McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285303McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285327McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285341McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285389McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285402McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285426McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285440McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285464McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285488McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285518McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285532McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285563McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285594McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285617McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285631McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285655McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285679McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
20612479285693McKessonMCKESSON MEDICAL-SURGICAL INC.GAT2026-05-26
00840277412010ApeTapeRIVERPOINT MEDICAL, LLCGAT2026-05-22
00840277412027ApeTapeRIVERPOINT MEDICAL, LLCGAT2026-05-22
10810020085218HS FiberRIVERPOINT MEDICAL, LLCGAT2026-03-16
10840277411768HS FiberRIVERPOINT MEDICAL, LLCGAT2026-03-16
10840277411775HS FiberRIVERPOINT MEDICAL, LLCGAT2026-03-16
10840277411782HS FiberRIVERPOINT MEDICAL, LLCGAT2026-03-16
10840277411799HS FiberRIVERPOINT MEDICAL, LLCGAT2026-03-16
00840277411808HS FiberRIVERPOINT MEDICAL, LLCGAT2026-03-16