FDA.reportPublic FDA data

Peri-Loc

Primary DI
00885556878422
Brand
Peri-Loc
Company
Smith & Nephew, Inc.
Model
E0017695-1
Catalog number
E0017695-1
Device description
GUIDE PIN SLEEVE - STRAIGHT HANDLE
Published
2022-04-28
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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556878422PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556878422008855568784228855568784220885556878422

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation sleeve, reusableA hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a reusable device.

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010479235ECHELON71342011713420112015-09-28
03596010479266ECHELON71342014713420142015-09-28
03596010479273ECHELON71342015713420152015-09-28
03596010479297ECHELON71342017713420172015-09-28
03596010479303ECHELON71342018713420182015-09-28
03596010479310ECHELON71342019713420192015-09-28
03596010479341ECHELON71343012713430122015-09-28
03596010459749SYNERGY71309109713091092015-08-30
03596010459756SYNERGY71309110713091102015-08-30
03596010459787SYNERGY71309113713091132015-08-30
03596010459794SYNERGY71309114713091142015-08-30
03596010459817SYNERGY71309116713091162015-08-30
03596010459831SYNERGY71309118713091182015-08-30
03596010479259ECHELON71342013713420132015-09-28
03596010479280ECHELON71342016713420162015-09-28
03596010479358ECHELON71343013713430132015-09-28
03596010479365ECHELON71343014713430142015-09-28
03596010479389ECHELON71343016713430162015-09-28
03596010479396ECHELON71343017713430172015-09-28
03596010479402ECHELON71343018713430182015-09-28

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Primary DI, Brand, Company table
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07613154320394MATTAStryker GmbHHRS2023-10-20
07613154320400MATTAStryker GmbHHRS2023-10-20
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07613154320455MATTAStryker GmbHHRS2023-10-20
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07613154320516MATTAStryker GmbHHRS2023-10-20
07613154320530MATTAStryker GmbHHRS2023-10-20
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07613154320608MATTAStryker GmbHHRS2023-10-20
07613154320622MATTAStryker GmbHHRS2023-10-20
07613154320653MATTAStryker GmbHHRS2023-10-20
07613154320677MATTAStryker GmbHHRS2023-10-20
07613154320707MATTAStryker GmbHHRS2023-10-20
07613154320714MATTAStryker GmbHHRS2023-10-20
07613154320721MATTAStryker GmbHHRS2023-10-20
07613154320752MATTAStryker GmbHHRS2023-10-20
07613154320783MATTAStryker GmbHHRS2023-10-20
07613154320790MATTAStryker GmbHHRS2023-10-20
07613154320806MATTAStryker GmbHHRS2023-10-20
07613154320813MATTAStryker GmbHHRS2023-10-20
07613154320882MATTAStryker GmbHHRS2023-10-20
07613154320943MATTAStryker GmbHHRS2023-10-20