Sgarlato Silastic

Primary DI
00819034029211
Brand
Sgarlato Silastic
Company
FUSION ORTHOPEDICS, LLC
Model
30-300-02-S
Catalog number
30-300-02-S
Device description
GAIT Pick and Press Inserter
Published
2023-07-14
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

Product Codes#

Code, Name table
CodeName
KWHProsthesis, Toe, Constrained, Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWHProsthesis, Toe, Constrained, PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819034029211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819034029211008190340292118190340292110819034029211

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080307067
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840124525603FibFixCD-FN-4037-SCD-FN-4037-S2026-05-11
00840124525610FibFixCD-FN-4047-SCD-FN-4047-S2026-05-11
00840124525627FibFixCD-FN-4057-SCD-FN-4057-S2026-05-11
00840124525634FibFixCD-FN-4037CD-FN-40372026-05-11
00840124525641FibFixCD-FN-4047CD-FN-40472026-05-11
00840124525658FibFixCD-FN-4057CD-FN-40572026-05-11
00840124521407Metalogix9003179003172025-09-30
00840124521414Metalogix9003209003202025-09-30
00840124525542FibFixTN-FN-9908TN-FN-99082026-04-23
00840124525559FibFixTN-FN-9912TN-FN-99122026-04-23
00840124525566FuzeFix LargeTN-FT-7096TN-FT-70962026-04-23
00840124525573FuzeFix LargeTN-FT-7070TN-FT-70702026-04-23
00840124525580FuzeFix LargeTN-FT-7024TN-FT-70242026-04-23
00840124525597FuzeFix LargeTN-FT-7050TN-FT-70502026-04-23
00819034022557TalarLift STS CD-TL-5050CD-TL-50502019-04-29
00840124525535Metalogix RevolutionTN-TR-0092TN-TR-00922026-04-17
00840124516113FibFixFN-SS-4014FN-SS-40142026-04-09
00840124516120FibFixFN-SS-40162026-04-09
00840124516137FibFixFN-SS-4018FN-SS-40182026-04-09
00840124516144FibFixFN-SS-4020FN-SS-40202026-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00819034029181Sgarlato SilasticFUSION ORTHOPEDICS, LLCKWH2023-07-14
00819034029198Sgarlato SilasticFUSION ORTHOPEDICS, LLCKWH2023-07-14
00840124507456Sgarlato SilasticFUSION ORTHOPEDICS, LLCKWH2023-07-14
00840124508989Sgarlato SilasticFUSION ORTHOPEDICS, LLCKWH2023-07-14
00885556834244Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834268Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834282Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834305Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834329Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834374Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834398Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834411Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834435Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834534Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834558Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834572Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834596Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
08057717550801Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550818Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550825Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550832Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550849Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550856Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550863Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550870Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550887Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550894Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
00840124506138Sgarlato SilasticFUSION ORTHOPEDICS, LLCKWH2021-08-18
00840124506145Sgarlato Silastic FUSION ORTHOPEDICS, LLCKWH2021-08-18
00840124506152Sgarlato Silastic FUSION ORTHOPEDICS, LLCKWH2021-08-18